OSSIO® Drill Bit & Drill Guide Pack

FDA UDI

Class I (US FDA UDI)

by Ossio Ltd

Identity

Trade Name: OSSIO® Drill Bit & Drill Guide Pack FDA UDI
Generic Name: Orthopaedic surgical procedure kit, non-medicated, single-use FDA UDI
Device Name: OSSIO® Drill Bit & Drill Guide Pack, For 5.5 mm Suture Anchor. Package contains: 1 Instrument Pack. FDA UDI
Model / Reference: THN00235 FDA UDI
Description: OSSIO® Drill Bit & Drill Guide Pack, For 5.5 mm Suture Anchor. Package contains: 1 Instrument Pack. FDA UDI

Identifiers

Catalog Number: THN00235 FDA UDI
Primary DI / UDI-DI: 07290017630953 FDA UDI
FDA Product Code: HTW FDA UDI
GMDN Term: Orthopaedic surgical procedure kit, non-medicated, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.4540 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Orthopaedic surgical procedure kit, non-medicated, single-use Fluted surgical drill bit, single-use Surgical drill guide, single-use

OSSIO® Drill Bit & Drill Guide Pack by Ossio Ltd — Class I — 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 I	Pending data

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Manufacturer

Manufacturer: Ossio Ltd

Sources (1)

FDA UDI 91637700-22ce-4392-9410-13e39abdfe4d 37 fields · synced Jun 1, 2026