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Tools - FPS

FDA UDI

Class I (US FDA UDI)

by Trimed, INC.

Identity

Trade Name
Tools - FPS FDA UDI
Generic Name
Bone-resection orthopaedic reamer, single-use FDA UDI
Device Name
FPS Cup Reamer, 20mm FDA UDI
Model / Reference
RMRFPS-20 FDA UDI
Description
FPS Cup Reamer, 20mm FDA UDI

Identifiers

Catalog Number
RMRFPS-20 FDA UDI
Primary DI / UDI-DI
00842188121432 FDA UDI
FDA Product Code
HTO FDA UDI
GMDN Term
Bone-resection orthopaedic reamer, 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

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Bone-resection orthopaedic reamer, single-use

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

Similar devices

Also classified as Bone-resection orthopaedic reamer, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Trimed, INC.

Sources (1)

  • FDA UDI 61c64bb3-fdc8-4f29-87e6-96c15c4bc87f 35 fields · synced Jun 1, 2026