Primary Device ID | 08800015961462 |
NIH Device Record Key | 6f3e487d-5f0e-4b36-80ec-1c2b6c03c77d |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Velofix™ TLIF Cage |
Version Model Number | TLA2513 |
Company DUNS | 688811082 |
Company Name | U&I CORPORATION |
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 | true |
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 | 08800015961462 [Primary] |
MAX | Intervertebral fusion device with bone graft, lumbar |
Steralize Prior To Use | true |
Device Is Sterile | false |
[08800015961462]
Moist Heat or Steam Sterilization
[08800015961462]
Moist Heat or Steam Sterilization
[08800015961462]
Moist Heat or Steam Sterilization
[08800015961462]
Moist Heat or Steam Sterilization
[08800015961462]
Moist Heat or Steam Sterilization
[08800015961462]
Moist Heat or Steam Sterilization
[08800015961462]
Moist Heat or Steam Sterilization
[08800015961462]
Moist Heat or Steam Sterilization
[08800015961462]
Moist Heat or Steam Sterilization
[08800015961462]
Moist Heat or Steam Sterilization
[08800015961462]
Moist Heat or Steam Sterilization
[08800015961462]
Moist Heat or Steam Sterilization
[08800015961462]
Moist Heat or Steam Sterilization
[08800015961462]
Moist Heat or Steam Sterilization
[08800015961462]
Moist Heat or Steam Sterilization
[08800015961462]
Moist Heat or Steam Sterilization
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2020-02-24 |
Device Publish Date | 2018-03-09 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() VELOFIX 86151986 4788231 Live/Registered |
Velofix Holdings Ltd. 2013-12-24 |
![]() VELOFIX 85885268 4827448 Live/Registered |
Velofix Holdings Ltd. 2013-03-25 |