| Primary Device ID | 03663136027609 |
| NIH Device Record Key | 92e3eac0-cdda-43c7-b7bd-da9ce376e173 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | U1-A111SH |
| Company DUNS | 390377518 |
| Company Name | SPINEVISION |
| 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 | 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 |
| Phone | +33153332525 |
| corp.quality@spinevision.com | |
| Phone | +33153332525 |
| corp.quality@spinevision.com | |
| Phone | +33153332525 |
| corp.quality@spinevision.com | |
| Phone | +33153332525 |
| corp.quality@spinevision.com | |
| Phone | +33153332525 |
| corp.quality@spinevision.com | |
| Phone | +33153332525 |
| corp.quality@spinevision.com | |
| Phone | +33153332525 |
| corp.quality@spinevision.com | |
| Phone | +33153332525 |
| corp.quality@spinevision.com | |
| Phone | +33153332525 |
| corp.quality@spinevision.com | |
| Phone | +33153332525 |
| corp.quality@spinevision.com | |
| Phone | +33153332525 |
| corp.quality@spinevision.com | |
| Phone | +33153332525 |
| corp.quality@spinevision.com | |
| Phone | +33153332525 |
| corp.quality@spinevision.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03663136027609 [Primary] |
| LXH | Orthopedic Manual Surgical Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[03663136027609]
Moist Heat or Steam Sterilization
[03663136027609]
Moist Heat or Steam Sterilization
[03663136027609]
Moist Heat or Steam Sterilization
[03663136027609]
Moist Heat or Steam Sterilization
[03663136027609]
Moist Heat or Steam Sterilization
[03663136027609]
Moist Heat or Steam Sterilization
[03663136027609]
Moist Heat or Steam Sterilization
[03663136027609]
Moist Heat or Steam Sterilization
[03663136027609]
Moist Heat or Steam Sterilization
[03663136027609]
Moist Heat or Steam Sterilization
[03663136027609]
Moist Heat or Steam Sterilization
[03663136027609]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2025-01-20 |
| Device Publish Date | 2016-02-03 |
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| 03663136009384 - Hexanium® ACIF | 2025-02-28 Convex Ti Cervical Cage Trial Without Stop |