ClosureRFS™
GUDID 00643169862999
STYLET RFS2-6-12 CLOSURE FAST V02
MEDTRONIC, INC.
Peripheral vascular electrocautery catheter, single-use Peripheral vascular electrocautery catheter, single-use| Primary Device ID | 00643169862999 |
| NIH Device Record Key | 2461f9e3-df57-455f-8f6a-40ab350536d3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ClosureRFS™ |
| Version Model Number | RFS2-6-12 |
| Company DUNS | 006261481 |
| Company Name | MEDTRONIC, 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 | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com |
Device Dimensions
| Catheter Gauge | 6 French |
| Catheter Gauge | 6 French |
| Catheter Gauge | 6 French |
| Catheter Gauge | 6 French |
| Catheter Gauge | 6 French |
| Catheter Gauge | 6 French |
Operating and Storage Conditions
| Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00643169862999 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K052003
FDA Product Code
| GEI | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-03-11 |
| Device Publish Date | 2017-05-14 |
On-Brand Devices [ClosureRFS™]
| 00643169862999 | STYLET RFS2-6-12 CLOSURE FAST V02 |
| 00763000723293 | STYLET RFS2-6-12 CLOSUREFAST |
Trademark Results [ClosureRFS]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CLOSURERFS 78981242 3738308 Live/Registered |
COVIDIEN LP 2005-11-15 |
 CLOSURERFS 78754642 not registered Dead/Abandoned |
VNUS Medical Technologies, Inc. 2005-11-15 |
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