Primary Device ID | 00843511112608 |
NIH Device Record Key | 6e468c99-7f0c-4ffa-94d9-1cca84e65683 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | TiBrid-A/SA |
Version Model Number | 14-5A-RMV2 |
Company DUNS | 079467378 |
Company Name | OMNIA MEDICAL, LLC |
Device Count | 1 |
DM Exempt | false |
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 | 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 | 3044134851 |
customerservice@omniamedical.com | |
Phone | 3044134851 |
customerservice@omniamedical.com | |
Phone | 3044134851 |
customerservice@omniamedical.com | |
Phone | 3044134851 |
customerservice@omniamedical.com | |
Phone | 3044134851 |
customerservice@omniamedical.com | |
Phone | 3044134851 |
customerservice@omniamedical.com | |
Phone | 3044134851 |
customerservice@omniamedical.com | |
Phone | 3044134851 |
customerservice@omniamedical.com | |
Phone | 3044134851 |
customerservice@omniamedical.com | |
Phone | 3044134851 |
customerservice@omniamedical.com | |
Phone | 3044134851 |
customerservice@omniamedical.com | |
Phone | 3044134851 |
customerservice@omniamedical.com | |
Phone | 3044134851 |
customerservice@omniamedical.com | |
Phone | 3044134851 |
customerservice@omniamedical.com | |
Phone | 3044134851 |
customerservice@omniamedical.com | |
Phone | 3044134851 |
customerservice@omniamedical.com | |
Phone | 3044134851 |
customerservice@omniamedical.com | |
Phone | 3044134851 |
customerservice@omniamedical.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00843511112608 [Primary] |
MAX | Intervertebral Fusion Device With Bone Graft, Lumbar |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00843511112608]
Moist Heat or Steam Sterilization
[00843511112608]
Moist Heat or Steam Sterilization
[00843511112608]
Moist Heat or Steam Sterilization
[00843511112608]
Moist Heat or Steam Sterilization
[00843511112608]
Moist Heat or Steam Sterilization
[00843511112608]
Moist Heat or Steam Sterilization
[00843511112608]
Moist Heat or Steam Sterilization
[00843511112608]
Moist Heat or Steam Sterilization
[00843511112608]
Moist Heat or Steam Sterilization
[00843511112608]
Moist Heat or Steam Sterilization
[00843511112608]
Moist Heat or Steam Sterilization
[00843511112608]
Moist Heat or Steam Sterilization
[00843511112608]
Moist Heat or Steam Sterilization
[00843511112608]
Moist Heat or Steam Sterilization
[00843511112608]
Moist Heat or Steam Sterilization
[00843511112608]
Moist Heat or Steam Sterilization
[00843511112608]
Moist Heat or Steam Sterilization
[00843511112608]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-12-25 |
Device Publish Date | 2024-12-17 |
00843511128142 - Omnia Medical Instruments | 2025-07-23 Soft Tissue Drill Bit Full Round |
00843511128258 - Omnia Medical Instruments | 2025-07-23 |
00843511128265 - Omnia Medical Instruments | 2025-07-23 TiBrid™ SA S Inserter, for 10, 12, 14mm heights |
00843511128272 - Omnia Medical Instruments | 2025-07-23 TiBrid™ SA S-Inserter for 16 and 18 heights |
00843511128296 - Omnia Medical Instruments | 2025-07-23 TiBrid SA Tack Inserter, 10mm and 12mm heights |
00843511128302 - Omnia Medical Instruments | 2025-07-23 TiBrid SA Tack Inserter, 14mm and 16mm heights |
00843511128319 - Omnia Medical Instruments | 2025-07-23 TiBrid SA Tack Inserter, 18mm heights |
00843511128326 - TiBrid-SA | 2025-07-23 TiBrid-SA Tack Inserter Driver |