Primary Device ID | 08800015995429 |
NIH Device Record Key | 60aee782-1395-48d2-bbb8-d7b05f345c62 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Velofix™ TLIF Cage |
Version Model Number | TL0400 |
Company DUNS | 688811082 |
Company Name | U&I CORPORATION |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
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 | 08800015995429 [Primary] |
FZT | CUTTER, SURGICAL |
Steralize Prior To Use | true |
Device Is Sterile | false |
[08800015995429]
Moist Heat or Steam Sterilization
[08800015995429]
Moist Heat or Steam Sterilization
[08800015995429]
Moist Heat or Steam Sterilization
[08800015995429]
Moist Heat or Steam Sterilization
[08800015995429]
Moist Heat or Steam Sterilization
[08800015995429]
Moist Heat or Steam Sterilization
[08800015995429]
Moist Heat or Steam Sterilization
[08800015995429]
Moist Heat or Steam Sterilization
[08800015995429]
Moist Heat or Steam Sterilization
[08800015995429]
Moist Heat or Steam Sterilization
[08800015995429]
Moist Heat or Steam Sterilization
[08800015995429]
Moist Heat or Steam Sterilization
[08800015995429]
Moist Heat or Steam Sterilization
[08800015995429]
Moist Heat or Steam Sterilization
[08800015995429]
Moist Heat or Steam Sterilization
[08800015995429]
Moist Heat or Steam Sterilization
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2019-05-07 |
Device Publish Date | 2018-05-31 |
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 |