TiBrid-A/SA

GUDID 00843511112608

TiBrid Rescue Tool

OMNIA MEDICAL, LLC

Orthopaedic inorganic implant inserter/extractor, reusable
Primary Device ID00843511112608
NIH Device Record Key6e468c99-7f0c-4ffa-94d9-1cca84e65683
Commercial Distribution StatusIn Commercial Distribution
Brand NameTiBrid-A/SA
Version Model Number14-5A-RMV2
Company DUNS079467378
Company NameOMNIA MEDICAL, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone3044134851
Emailcustomerservice@omniamedical.com
Phone3044134851
Emailcustomerservice@omniamedical.com
Phone3044134851
Emailcustomerservice@omniamedical.com
Phone3044134851
Emailcustomerservice@omniamedical.com
Phone3044134851
Emailcustomerservice@omniamedical.com
Phone3044134851
Emailcustomerservice@omniamedical.com
Phone3044134851
Emailcustomerservice@omniamedical.com
Phone3044134851
Emailcustomerservice@omniamedical.com
Phone3044134851
Emailcustomerservice@omniamedical.com
Phone3044134851
Emailcustomerservice@omniamedical.com
Phone3044134851
Emailcustomerservice@omniamedical.com
Phone3044134851
Emailcustomerservice@omniamedical.com
Phone3044134851
Emailcustomerservice@omniamedical.com
Phone3044134851
Emailcustomerservice@omniamedical.com
Phone3044134851
Emailcustomerservice@omniamedical.com
Phone3044134851
Emailcustomerservice@omniamedical.com
Phone3044134851
Emailcustomerservice@omniamedical.com
Phone3044134851
Emailcustomerservice@omniamedical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100843511112608 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[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


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-12-25
Device Publish Date2024-12-17

Devices Manufactured by OMNIA MEDICAL, LLC

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00843511113759 - Omnia Medical PSiFDNA2025-09-30 PsiF DNA Screw, 44mm
00843511113766 - Omnia Medical PSiFDNA2025-09-30 PsiF DNA Staple Tower
00843511122768 - Omnia Medical PSiFDNA2025-09-30 PsiF DNA Driver
00843511122775 - Omnia Medical PSiFDNA2025-09-30 PsiF DNA Impactor
00843511122799 - Omnia Medical PSiFDNA2025-09-30 PsiF DNA Drill
00843511122805 - Omnia Medical PSiFDNA2025-09-30 PsiF DNA Instrument Tray

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