Drill bit AO QC 3.5 x 195mm, Sterile

FDA UDI

Class I (US FDA UDI)

by Biopro, Inc.

Identity

Trade Name: Drill bit AO QC 3.5 x 195mm, Sterile FDA UDI
Generic Name: Fluted surgical drill bit, single-use FDA UDI
Model / Reference: OL35DBSL FDA UDI

Identifiers

Primary DI / UDI-DI: 00810012483544 FDA UDI
FDA Product Code: HTW FDA UDI
GMDN Term: Fluted surgical drill bit, 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

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

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Fluted surgical drill bit, single-use

Drill bit AO QC 3.5 x 195mm, Sterile by Biopro, Inc. — 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: Biopro, Inc.

Sources (1)

FDA UDI 0517961b-c4da-4f83-b6f6-2ea4cb1757b4 32 fields · synced May 30, 2026