Omnia Medical Coupler-C

FDA UDI

Class II (US FDA UDI)

by Omnia Medical

Identity

Trade Name: Omnia Medical Coupler-C FDA UDI
Generic Name: Fluted surgical drill bit, reusable FDA UDI
Device Name: CERVICAL DRILL, Ø4.0 X 8 MM FDA UDI
Model / Reference: 15-5C-DRL1 FDA UDI
Description: CERVICAL DRILL, Ø4.0 X 8 MM FDA UDI

Identifiers

Catalog Number: 15-5C-DRL1 FDA UDI
Primary DI / UDI-DI: 00843511113568 FDA UDI
FDA Product Code: KWQ FDA UDI
GMDN Term: Fluted surgical drill bit, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3060 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: Outer Diameter — 4 Millimeter FDA UDI
Length — 8 Millimeter FDA UDI

Category: Fluted surgical drill bit, reusable

Omnia Medical Coupler-C by Omnia Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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

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Manufacturer

Manufacturer: Omnia Medical

Sources (1)

FDA UDI ee55de40-a4bc-4699-93f7-9bf1b089cf96 36 fields · synced Jun 1, 2026