Primary Device ID | 00814729025370 |
NIH Device Record Key | 8eb5e455-cba8-4b2a-bfff-8fdee502081f |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | InFill Contour TLIF |
Version Model Number | 43-05-102615 |
Company DUNS | 962347980 |
Company Name | PINNACLE SPINE GROUP, 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 | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | true |
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 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00814729025370 [Primary] |
MAX | Intervertebral Fusion Device With Bone Graft, Lumbar |
Steralize Prior To Use | true |
Device Is Sterile | true |
[00814729025370]
Radiation Sterilization;Moist Heat or Steam Sterilization
[00814729025370]
Radiation Sterilization;Moist Heat or Steam Sterilization
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 4 |
Public Version Date | 2019-04-23 |
Device Publish Date | 2016-08-26 |
00814729025479 | 43-05-103016 |
00814729025462 | 43-05-103015 |
00814729025455 | 43-05-103014 |
00814729025448 | 43-05-103013 |
00814729025431 | 43-05-103012 |
00814729025424 | 43-05-103011 |
00814729025417 | 43-05-103010 |
00814729025400 | 43-05-103009 |
00814729025394 | 43-05-103008 |
00814729025387 | 43-05-102616 |
00814729025370 | 43-05-102615 |
00814729025363 | 43-05-102614 |
00814729025356 | 43-05-102613 |
00814729025349 | 43-05-102612 |
00814729025332 | 43-05-102611 |
00814729025325 | 43-05-102610 |
00814729025318 | 43-05-102609 |
00814729025301 | 43-05-102608 |