CORNERSTONE® PSR System
GUDID 00885074354323
INSERTER 6279002 PSR ENDCAP THREADED
MEDTRONIC SOFAMOR DANEK, INC.
Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable| Primary Device ID | 00885074354323 |
| NIH Device Record Key | 67df7d70-bae0-464a-b570-b0c9da632745 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CORNERSTONE® PSR System |
| Version Model Number | 6279002 |
| Company DUNS | 830350380 |
| Company Name | MEDTRONIC SOFAMOR DANEK, 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 | false |
| 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
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00885074354323 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K111264
FDA Product Code
| MQP | SPINAL VERTEBRAL BODY REPLACEMENT DEVICE |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00885074354323]
Moist Heat or Steam Sterilization
[00885074354323]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 6 |
| Public Version Date | 2019-04-23 |
| Device Publish Date | 2015-08-19 |
On-Brand Devices [CORNERSTONE® PSR System]
| 00885074354323 | INSERTER 6279002 PSR ENDCAP THREADED |
| 00885074177717 | INSERTER 875-782 CSTONE II DUAL PIVOT |
| 00885074372006 | CORNERSTONE PSR OUTER CASE |
Trademark Results [CORNERSTONE]
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