| Primary Device ID | 08800015995443 |
| NIH Device Record Key | 19968307-16ab-43ed-8cbb-ebcb5a0e22ac |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Velofix™ TLIF Cage |
| Version Model Number | TL0420 |
| 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 | 08800015995443 [Primary] |
| FZT | CUTTER, SURGICAL |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08800015995443]
Moist Heat or Steam Sterilization
[08800015995443]
Moist Heat or Steam Sterilization
[08800015995443]
Moist Heat or Steam Sterilization
[08800015995443]
Moist Heat or Steam Sterilization
[08800015995443]
Moist Heat or Steam Sterilization
[08800015995443]
Moist Heat or Steam Sterilization
[08800015995443]
Moist Heat or Steam Sterilization
[08800015995443]
Moist Heat or Steam Sterilization
[08800015995443]
Moist Heat or Steam Sterilization
[08800015995443]
Moist Heat or Steam Sterilization
[08800015995443]
Moist Heat or Steam Sterilization
[08800015995443]
Moist Heat or Steam Sterilization
[08800015995443]
Moist Heat or Steam Sterilization
[08800015995443]
Moist Heat or Steam Sterilization
[08800015995443]
Moist Heat or Steam Sterilization
[08800015995443]
Moist Heat or Steam Sterilization
[08800015995443]
Moist Heat or Steam Sterilization
[08800015995443]
Moist Heat or Steam Sterilization
[08800015995443]
Moist Heat or Steam Sterilization
[08800015995443]
Moist Heat or Steam Sterilization
[08800015995443]
Moist Heat or Steam Sterilization
[08800015995443]
Moist Heat or Steam Sterilization
[08800015995443]
Moist Heat or Steam Sterilization
[08800015995443]
Moist Heat or Steam Sterilization
[08800015995443]
Moist Heat or Steam Sterilization
[08800015995443]
Moist Heat or Steam Sterilization
[08800015995443]
Moist Heat or Steam Sterilization
[08800015995443]
Moist Heat or Steam Sterilization
[08800015995443]
Moist Heat or Steam Sterilization
[08800015995443]
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 |