Acumed

FDA UDI

Class I (US FDA UDI)

by Acumed Llc

Identity

Trade Name: ACUMED FDA UDI
Generic Name: Cannulated surgical drill bit, single-use FDA UDI
Device Name: 6mm BGH 2 Kit FDA UDI
Model / Reference: 46-0034-S FDA UDI
Description: 6mm BGH 2 Kit FDA UDI

Identifiers

Primary DI / UDI-DI: 10806378123382 FDA UDI
FDA Product Code: KIJ FDA UDI
GMDN Term: Cannulated surgical drill bit, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4820 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

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Cannulated surgical drill bit, single-use

Acumed by Acumed Llc — 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: Acumed Llc

Sources (1)

FDA UDI 316b43d6-b45a-4f1f-abc1-b2ee8b69b195 34 fields · synced Jun 8, 2026