Omnia Medical TiBrid™-C

FDA UDI

Class II (US FDA UDI)

by Omnia Medical

Identity

Trade Name: Omnia Medical TiBrid™-C FDA UDI
Generic Name: Bone file/rasp, manual, reusable FDA UDI
Device Name: CONVEX RASP, 05mm FDA UDI
Model / Reference: 07-5C-RA05 FDA UDI
Description: CONVEX RASP, 05mm FDA UDI

Identifiers

Catalog Number: 07-5C-RA05 FDA UDI
Primary DI / UDI-DI: 00843511102043 FDA UDI
510(k) Number: K190363 FDA UDI
FDA Product Code: ODP FDA UDI
GMDN Term: Bone file/rasp, manual, 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 — 5 Millimeter FDA UDI

Category: Bone file/rasp, manual, reusable

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

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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

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Manufacturer

Manufacturer: Omnia Medical

Sources (1)

FDA UDI 97a7497e-1710-4546-9cce-868fdb03d061 37 fields · synced Jun 1, 2026