Omnia Medical TiBrid™-SC

FDA UDI

Class II (US FDA UDI)

by Omnia Medical

Identity

Trade Name: Omnia Medical TiBrid™-SC FDA UDI
Generic Name: Surgical drill guide, reusable FDA UDI
Device Name: TIBRID-SC PLATE DRILL GUIDE 9mm FDA UDI
Model / Reference: 10-5C-DR09 FDA UDI
Description: TIBRID-SC PLATE DRILL GUIDE 9mm FDA UDI

Identifiers

Catalog Number: 10-5C-DR09 FDA UDI
Primary DI / UDI-DI: 00843511123260 FDA UDI
510(k) Number: K212612 FDA UDI
FDA Product Code: OVE FDA UDI
GMDN Term: Surgical drill guide, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3080 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size: Height — 9 Millimeter FDA UDI

Category: Surgical drill guide, reusable

Omnia Medical TiBrid™-SC by Omnia Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical drill guide, reusable.

ORTHOFIX — Orthofix, Inc. · Class I
Titan™ — Ascension Orthopedics, Inc. · Class I
Medtronic Resuable Instruments — MEDTRONIC SOFAMOR DANEK, INC. · Class I
Distal Elbow Plating System — SKELETAL DYNAMICS L.L.C. · Class II
Truliant — Exactech, Inc. · Class II
Vantage — Exactech, Inc. · Class II
Legion — Smith & Nephew, Inc. · Class II
Hintermann Series — Dt Medtech, LLC · Class I

Cleared under the same submission

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Omnia Medical

Sources (1)

FDA UDI b1599f6e-258d-4794-92e8-059a13979b14 37 fields · synced Jun 6, 2026