Acumed

FDA UDI

Class I (US FDA UDI)

by Acumed Llc

Identity

Trade Name: ACUMED FDA UDI
Generic Name: Surgical countersink, reusable FDA UDI
Device Name: CO/CA Countersink FDA UDI
Model / Reference: PL-2080 FDA UDI
Description: CO/CA Countersink FDA UDI

Identifiers

Primary DI / UDI-DI: 10806378074547 FDA UDI
FDA Product Code: LXH FDA UDI
GMDN Term: Surgical countersink, 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: Surgical countersink, reusable

Acumed by Acumed Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical countersink, reusable.

WIDE COUNTERSINK DRILL - LONG — BIOTECHNOLOGY INSTITUTE SL · Class I
Zimmer Cannulated Screw System — Pioneer Surgical Technology, Inc. · Class I
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COUNTERSINK SMALL FRAG — Biomet Orthopedics, Inc. · Class I
Cortical Counter Sink — I.T.S. GmbH · Class I
EVOS — Smith & Nephew, Inc. · Class I
PERLA ® — Spineart · Class II
DART-FIRE — WRIGHT MEDICAL TECHNOLOGY, INC. · Class I

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 d4b230c3-e972-43a7-8d6a-8b1c1f7c44bb 34 fields · synced Jun 8, 2026