REACT™
GUDID 00847536044197
CATHETER REACT-71 V03 eIFU
Micro Therapeutics, Inc.
Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use| Primary Device ID | 00847536044197 |
| NIH Device Record Key | 6fa0a164-cadb-45ad-a50f-bae733a2bddf |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | REACT™ |
| Version Model Number | REACT-71 |
| Company DUNS | 826110710 |
| Company Name | Micro Therapeutics, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry cool place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry cool place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry cool place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry cool place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry cool place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry cool place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry cool place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry cool place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry cool place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry cool place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry cool place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry cool place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry cool place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry cool place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry cool place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry cool place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry cool place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry cool place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry cool place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry cool place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry cool place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry cool place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry cool place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry cool place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry cool place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry cool place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry cool place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry cool place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry cool place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry cool place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry cool place |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00847536044197 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K182097
FDA Product Code
| DQY | Catheter, percutaneous |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-03-26 |
| Device Publish Date | 2021-03-18 |
On-Brand Devices [REACT™]
| 00847536044197 | CATHETER REACT-71 V03 eIFU |
| 00847536041967 | CATHETER REACT-68 V03 eIFU |
Trademark Results [REACT]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 REACT 98343573 not registered Live/Pending |
Kaarya LLC 2024-01-05 |
 REACT 98011848 not registered Live/Pending |
Konica Minolta Business Solutions U.S.A., Inc. 2023-05-24 |
 REACT 97842240 not registered Live/Pending |
Arelac, Inc. 2023-03-16 |
 REACT 97748413 not registered Live/Pending |
Recycap Technologies, S.L. 2023-01-10 |
 REACT 90801399 not registered Live/Pending |
Harbor Bay Group, Inc. 2021-06-29 |
 REACT 90801382 not registered Live/Pending |
Harbor Bay Group, Inc. 2021-06-29 |
 REACT 90736545 not registered Live/Pending |
Encompass Health Corporation 2021-05-26 |
 REACT 90732793 not registered Live/Pending |
ProKidney 2021-05-25 |
 REACT 90479856 not registered Live/Pending |
Limitless Innovations, Inc. 2021-01-21 |
 REACT 90479840 not registered Live/Pending |
Limitless Innovations, Inc. 2021-01-21 |
 REACT 90245527 not registered Live/Pending |
Cardiac Advanced Resuscitation Education, LLC 2020-10-09 |
 REACT 90151698 not registered Live/Pending |
S. Rays, Inc. 2020-09-01 |
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