FDA.reportPublic FDA data

Omnia Medical TiBrid™- A/SA

Primary DI
00843511123093
Brand
Omnia Medical TiBrid™- A/SA
Company
OMNIA MEDICAL, LLC
Model
17-5A-BT09
Device description
TiBrid™-SA Bullet Trial, 9mm
Published
2023-10-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GCZRetainer, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCZRetainer, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00843511123093PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00843511123093008435111230938435111230930843511123093

GMDN Terms#

Term, Definition table
TermDefinition
Surgical implant/trial-implant/sizer holder, reusableA hand-held manual surgical instrument designed to connect to and hold an implant (e.g., bone screw, bone graft), trial implant, or implantable device sizer/template (e.g., glenoid defect sizer, hearing implant template) to facilitate guidance, gauging/sizing, and/or monitoring of the held device during orthopaedic or ear/nose/throat (ENT) surgery. The instrument is typically made of metal or synthetic polymer materials and is typically constructed in the form of a long shaft with a handle at the proximal end and a device holding/fixation mechanism at the distal end. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height9Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
3044134851customerservice@omniamedical.com

Regulatory Flags#

DUNS number
079467378
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00843511102586Omnia Medical TiBrid™-TS09-0P-102208-102026-08-03
00843511102593Omnia Medical TiBrid™-TS09-0P-102209-102026-08-03
00843511102609Omnia Medical TiBrid™-TS09-0P-102210-102026-08-03
00843511102616Omnia Medical TiBrid™-TS09-0P-102211-102026-08-03
00843511102623Omnia Medical TiBrid™-TS09-0P-102212-102026-08-03
00843511102630Omnia Medical TiBrid™-TS09-0P-102213-102026-08-03
00843511102647Omnia Medical TiBrid™-TS09-0P-102214-102026-08-03
00843511102654Omnia Medical TiBrid™-TS09-0P-102215-102026-08-03
00843511102661Omnia Medical TiBrid™-TS09-0P-102216-102026-08-03
00843511102678Omnia Medical TiBrid™-TS09-0P-102209-152026-08-03
00843511102685Omnia Medical TiBrid™-TS09-0P-102210-152026-08-03
00843511102692Omnia Medical TiBrid™-TS09-0P-102211-152026-08-03
00843511102708Omnia Medical TiBrid™-TS09-0P-102212-152026-08-03
00843511102715Omnia Medical TiBrid™-TS09-0P-102213-152026-08-03
00843511102722Omnia Medical TiBrid™-TS09-0P-102214-152026-08-03
00843511102739Omnia Medical TiBrid™-TS09-0P-102215-152026-08-03
00843511102746Omnia Medical TiBrid™-TS09-0P-102216-152026-08-03
00843511102753Omnia Medical TiBrid™-TS09-0P-102607-102026-08-03
00843511102760Omnia Medical TiBrid™-TS09-0P-102608-102026-08-03
00843511102777Omnia Medical TiBrid™-TS09-0P-102609-102026-08-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00843511123086Omnia Medical TiBrid™- A/SA OMNIA MEDICAL, LLCGCZ2023-10-18
00843511123109Omnia Medical TiBrid™- A/SA OMNIA MEDICAL, LLCGCZ2023-10-18
00843511123116Omnia Medical TiBrid™- A/SA OMNIA MEDICAL, LLCGCZ2023-10-18
00843511123123Omnia Medical TiBrid™- A/SA OMNIA MEDICAL, LLCGCZ2023-10-18
00843511123130Omnia Medical TiBrid™- A/SA OMNIA MEDICAL, LLCGCZ2023-10-18
00843511123147Omnia Medical TiBrid™- A/SA OMNIA MEDICAL, LLCGCZ2023-10-18
00613244000011Viscera Retainer, FishADEPT MED INTERNATIONAL INCGCZ2023-02-16
00613244000028Viscera Retainer, FishADEPT MED INTERNATIONAL INCGCZ2023-02-16
00613244000035Viscera Retainer, FishADEPT MED INTERNATIONAL INCGCZ2023-02-16
00613244000042Viscera Retainer, FishADEPT MED INTERNATIONAL INCGCZ2023-02-16
00613244000066Viscera Retainer, FishADEPT MED INTERNATIONAL INCGCZ2023-02-16
00613244000004Viscera Retainer, FishADEPT MED INTERNATIONAL INCGCZ2023-02-16
61324400001100Viscera Retainer, FishADEPT MED INTERNATIONAL INCGCZ2023-02-16
61324400002800Viscera Retainer, FishADEPT MED INTERNATIONAL INCGCZ2023-02-16
61324400003500Viscera Retainer, FishADEPT MED INTERNATIONAL INCGCZ2023-02-16
61324400004200Viscera Retainer, FishADEPT MED INTERNATIONAL INCGCZ2023-02-16
00613244000059Breast Implant ProtectorADEPT MED INTERNATIONAL INCGCZ2023-02-16
61324400006600Viscera Retainer, FishADEPT MED INTERNATIONAL INCGCZ2023-02-16
90841823104260Anchor Bolt Kit, LSB StyleAD-TECH MEDICAL INSTRUMENT CORPORATIONGCZ2021-08-10
90841823104277Anchor Bolt Kit, LSB StyleAD-TECH MEDICAL INSTRUMENT CORPORATIONGCZ2021-08-10
90841823104284Anchor Bolt Kit, LSB StyleAD-TECH MEDICAL INSTRUMENT CORPORATIONGCZ2021-08-10
90841823104291Anchor Bolt Kit, LSB StyleAD-TECH MEDICAL INSTRUMENT CORPORATIONGCZ2021-08-10
90841823104307Anchor Bolt Kit, LSB StyleAD-TECH MEDICAL INSTRUMENT CORPORATIONGCZ2021-08-10
90841823104314Anchor Bolt Kit, LSB StyleAD-TECH MEDICAL INSTRUMENT CORPORATIONGCZ2021-08-10
90841823104321Anchor Bolt Kit, LSB StyleAD-TECH MEDICAL INSTRUMENT CORPORATIONGCZ2021-08-10
90841823104338Anchor Bolt Kit, LSB StyleAD-TECH MEDICAL INSTRUMENT CORPORATIONGCZ2021-08-10
90841823104345Anchor Bolt Kit, LSB StyleAD-TECH MEDICAL INSTRUMENT CORPORATIONGCZ2021-08-10
00816101010363Cross Element Guide RetainerTOBY ORTHOPAEDICSGCZ2020-08-28
00816101010370Cross Element Guide SleeveTOBY ORTHOPAEDICSGCZ2020-08-28
00816101010394Post Drill Guide Sleeve, 28mmTOBY ORTHOPAEDICSGCZ2020-08-28