Accu-Joint

FDA UDI

Class I (US FDA UDI)

by Accufix Surgical, Inc.

Identity

Trade Name: Accu-Joint FDA UDI
Generic Name: Cannulated surgical drill bit, reusable FDA UDI
Device Name: Drill Bit 1.70mmX80mm, w/1.00 Cannulation, 10mm depth, AO FDA UDI
Model / Reference: AJD1.70-10 FDA UDI
Description: Drill Bit 1.70mmX80mm, w/1.00 Cannulation, 10mm depth, AO FDA UDI

Identifiers

Catalog Number: AJD1.70-10 FDA UDI
Primary DI / UDI-DI: 00850044114030 FDA UDI
FDA Product Code: HTW FDA UDI
GMDN Term: Cannulated surgical drill bit, reusable 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

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

Yes

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

Category: Cannulated surgical drill bit, reusable

Accu-Joint by Accufix Surgical, 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: Accufix Surgical, Inc.

Sources (1)

FDA UDI f1e4fcbd-e1da-4524-b858-4532d9a6be27 34 fields · synced Jun 6, 2026