Primary Device ID | 04260148898273 |
NIH Device Record Key | fa1c3b0e-ebd5-4e3e-961c-8454af871292 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | CoFix Implant 16 mm |
Version Model Number | RQI00016 |
Catalog Number | RQI00016 |
Company DUNS | 787874960 |
Company Name | Paradigm Spine, LLC |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | MR Conditional |
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 | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Height | 16 Millimeter |
Height | 16 Millimeter |
Height | 16 Millimeter |
Height | 16 Millimeter |
Height | 16 Millimeter |
Height | 16 Millimeter |
Height | 16 Millimeter |
Height | 16 Millimeter |
Height | 16 Millimeter |
Height | 16 Millimeter |
Height | 16 Millimeter |
Height | 16 Millimeter |
Height | 16 Millimeter |
Height | 16 Millimeter |
Height | 16 Millimeter |
Height | 16 Millimeter |
Height | 16 Millimeter |
Height | 16 Millimeter |
Height | 16 Millimeter |
Height | 16 Millimeter |
Height | 16 Millimeter |
Height | 16 Millimeter |
Height | 16 Millimeter |
Height | 16 Millimeter |
Height | 16 Millimeter |
Height | 16 Millimeter |
Height | 16 Millimeter |
Height | 16 Millimeter |
Height | 16 Millimeter |
Device Issuing Agency | Device ID |
---|---|
GS1 | 04260148898273 [Primary] |
PEK | Spinous Process Plate |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2020-03-27 |
Device Publish Date | 2020-03-19 |
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 |
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 |