VELOFIX™ PEEK CERVICAL CAGE
GUDID 08800015959902
U&I CORPORATION
Orthopaedic implant inserter/extractor, reusable| Primary Device ID | 08800015959902 |
| NIH Device Record Key | 34b8d0b5-ebad-4a91-9c51-88cea495a54d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | VELOFIX™ PEEK CERVICAL CAGE |
| Version Model Number | PES0010 |
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08800015959902 [Primary] |
FDA Product Code
| FZX | Guide, surgical, instrument |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08800015959902]
Moist Heat or Steam Sterilization
[08800015959902]
Moist Heat or Steam Sterilization
[08800015959902]
Moist Heat or Steam Sterilization
[08800015959902]
Moist Heat or Steam Sterilization
[08800015959902]
Moist Heat or Steam Sterilization
[08800015959902]
Moist Heat or Steam Sterilization
[08800015959902]
Moist Heat or Steam Sterilization
[08800015959902]
Moist Heat or Steam Sterilization
[08800015959902]
Moist Heat or Steam Sterilization
[08800015959902]
Moist Heat or Steam Sterilization
[08800015959902]
Moist Heat or Steam Sterilization
[08800015959902]
Moist Heat or Steam Sterilization
[08800015959902]
Moist Heat or Steam Sterilization
[08800015959902]
Moist Heat or Steam Sterilization
[08800015959902]
Moist Heat or Steam Sterilization
[08800015959902]
Moist Heat or Steam Sterilization
[08800015959902]
Moist Heat or Steam Sterilization
[08800015959902]
Moist Heat or Steam Sterilization
[08800015959902]
Moist Heat or Steam Sterilization
[08800015959902]
Moist Heat or Steam Sterilization
[08800015959902]
Moist Heat or Steam Sterilization
[08800015959902]
Moist Heat or Steam Sterilization
[08800015959902]
Moist Heat or Steam Sterilization
[08800015959902]
Moist Heat or Steam Sterilization
[08800015959902]
Moist Heat or Steam Sterilization
[08800015959902]
Moist Heat or Steam Sterilization
[08800015959902]
Moist Heat or Steam Sterilization
[08800015959902]
Moist Heat or Steam Sterilization
[08800015959902]
Moist Heat or Steam Sterilization
[08800015959902]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2019-04-23 |
| Device Publish Date | 2017-11-16 |
On-Brand Devices [VELOFIX™ PEEK CERVICAL CAGE]
Trademark Results [VELOFIX]
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 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.