Primary Device ID | 00190837017835 |
NIH Device Record Key | a92cc4fa-e954-49ac-814f-e484af89ae80 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Plateau-Z 10mm x 24mm x 13mm, 0° |
Version Model Number | 43-1024-13 |
Company DUNS | 183641617 |
Company Name | Life Spine, Inc. |
Device Count | 1 |
DM Exempt | true |
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 | 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 Issuing Agency | Device ID |
---|---|
GS1 | 00190837017835 [Primary] |
MAX | Intervertebral Fusion Device With Bone Graft, Lumbar |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00190837017835]
Moist Heat or Steam Sterilization
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 4 |
Public Version Date | 2020-02-24 |
Device Publish Date | 2016-12-20 |
00190837175214 - ARx SAI | 2024-12-16 |
00190837175177 - ARx SAI | 2024-12-12 |
00190837175191 - ARx SAI | 2024-12-12 |
00190837175238 - ARx SAI | 2024-12-12 |
00190837175382 - ARx SAI | 2024-12-12 |
00190837153410 - TruLift Lateral | 2024-10-25 |
00190837142209 - ProLift | 2024-10-18 |
00190837142278 - ProLift | 2024-10-18 |