Tools - HCS

FDA UDI

Class I (US FDA UDI)

by Trimed, INC.

Identity

Trade Name: Tools - HCS FDA UDI
Generic Name: Surgical countersink, reusable FDA UDI
Device Name: Countersink 3.5mm, CSS FDA UDI
Model / Reference: CSINK-3.5 FDA UDI
Description: Countersink 3.5mm, CSS FDA UDI

Identifiers

Catalog Number: CSINK-3.5 FDA UDI
Primary DI / UDI-DI: 00842188111426 FDA UDI
FDA Product Code: HWW 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

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Surgical countersink, reusable

Tools - HCS by Trimed, INC. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Trimed, INC.

Sources (1)

FDA UDI e35584e0-9976-4435-9794-810e8c178f2c 35 fields · synced May 31, 2026