coflex-F™ Sterilization tray
GUDID 04260148890321
Paradigm Spine, LLC
Sterilization container| Primary Device ID | 04260148890321 |
| NIH Device Record Key | 1676c83a-601d-461d-89e4-5b605026e8e5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | coflex-F™ Sterilization tray |
| Version Model Number | RAC00000 |
| Company DUNS | 787874960 |
| Company Name | Paradigm Spine, LLC |
| 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04260148890321 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K093438
FDA Product Code
| KWP | Appliance, Fixation, Spinal Interlaminal |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[04260148890321]
Moist Heat or Steam Sterilization
[04260148890321]
Moist Heat or Steam Sterilization
[04260148890321]
Moist Heat or Steam Sterilization
[04260148890321]
Moist Heat or Steam Sterilization
[04260148890321]
Moist Heat or Steam Sterilization
[04260148890321]
Moist Heat or Steam Sterilization
[04260148890321]
Moist Heat or Steam Sterilization
[04260148890321]
Moist Heat or Steam Sterilization
[04260148890321]
Moist Heat or Steam Sterilization
[04260148890321]
Moist Heat or Steam Sterilization
[04260148890321]
Moist Heat or Steam Sterilization
[04260148890321]
Moist Heat or Steam Sterilization
[04260148890321]
Moist Heat or Steam Sterilization
[04260148890321]
Moist Heat or Steam Sterilization
[04260148890321]
Moist Heat or Steam Sterilization
[04260148890321]
Moist Heat or Steam Sterilization
[04260148890321]
Moist Heat or Steam Sterilization
[04260148890321]
Moist Heat or Steam Sterilization
[04260148890321]
Moist Heat or Steam Sterilization
[04260148890321]
Moist Heat or Steam Sterilization
[04260148890321]
Moist Heat or Steam Sterilization
[04260148890321]
Moist Heat or Steam Sterilization
[04260148890321]
Moist Heat or Steam Sterilization
[04260148890321]
Moist Heat or Steam Sterilization
[04260148890321]
Moist Heat or Steam Sterilization
[04260148890321]
Moist Heat or Steam Sterilization
[04260148890321]
Moist Heat or Steam Sterilization
[04260148890321]
Moist Heat or Steam Sterilization
[04260148890321]
Moist Heat or Steam Sterilization
[04260148890321]
Moist Heat or Steam Sterilization
[04260148890321]
Moist Heat or Steam Sterilization
[04260148890321]
Moist Heat or Steam Sterilization
[04260148890321]
Moist Heat or Steam Sterilization
[04260148890321]
Moist Heat or Steam Sterilization
[04260148890321]
Moist Heat or Steam Sterilization
[04260148890321]
Moist Heat or Steam Sterilization
[04260148890321]
Moist Heat or Steam Sterilization
[04260148890321]
Moist Heat or Steam Sterilization
[04260148890321]
Moist Heat or Steam Sterilization
[04260148890321]
Moist Heat or Steam Sterilization
[04260148890321]
Moist Heat or Steam Sterilization
[04260148890321]
Moist Heat or Steam Sterilization
[04260148890321]
Moist Heat or Steam Sterilization
[04260148890321]
Moist Heat or Steam Sterilization
[04260148890321]
Moist Heat or Steam Sterilization
[04260148890321]
Moist Heat or Steam Sterilization
[04260148890321]
Moist Heat or Steam Sterilization
[04260148890321]
Moist Heat or Steam Sterilization
[04260148890321]
Moist Heat or Steam Sterilization
[04260148890321]
Moist Heat or Steam Sterilization
[04260148890321]
Moist Heat or Steam Sterilization
[04260148890321]
Moist Heat or Steam Sterilization
[04260148890321]
Moist Heat or Steam Sterilization
[04260148890321]
Moist Heat or Steam Sterilization
[04260148890321]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-06-29 |
Devices Manufactured by Paradigm Spine, LLC
| 04260148898235 - CoFix Implant 8 mm | 2020-03-27 |
| 04260148898242 - CoFix Implant 10 mm | 2020-03-27 |
| 04260148898259 - CoFix Implant 12 mm | 2020-03-27 |
| 04260148898266 - CoFix Implant 14 mm | 2020-03-27 |
| 04260148898273 - CoFix Implant 16 mm | 2020-03-27 |
| 04260148897931 - CoFix Sterilization Tray | 2020-03-12 |
| 04260636670459 - coflex-F LIS screw inserter | 2020-03-12 |
| 04260148896927 - DSS HP Polyaxial pedicle screw set, Ø5 x 45mm | 2019-09-26 |
Trademark Results [coflex-F]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 COFLEX-F 77942097 3955728 Live/Registered |
Paradigm Spine, LLC 2010-02-23 |
 COFLEX-F 77027203 not registered Dead/Abandoned |
Paradigm Spine, LLC 2006-10-23 |
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