Primary Device ID | 00814729024748 |
NIH Device Record Key | 39311acb-4873-44a8-b540-715e8b139e43 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | InFIll Lateral Lordotic |
Version Model Number | 54-4510 |
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 | 00814729024748 [Primary] |
MAX | Intervertebral Fusion Device With Bone Graft, Lumbar |
Steralize Prior To Use | true |
Device Is Sterile | true |
[00814729024748]
Radiation Sterilization;Moist Heat or Steam Sterilization
[00814729024748]
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 |
00814729024847 | 54-6012 |
00814729024830 | 54-6010 |
00814729024823 | 54-6008 |
00814729024816 | 54-5512 |
00814729024809 | 54-5510 |
00814729024793 | 54-5508 |
00814729024786 | 54-5012 |
00814729024779 | 54-5010 |
00814729024762 | 54-5008 |
00814729024755 | 54-4512 |
00814729024748 | 54-4510 |
00814729024731 | 54-4508 |
00814729024724 | 54-4012 |
00814729024717 | 54-4010 |
00814729024700 | 54-4008 |