CRP™ Cuff Repair Plate System

FDA UDI

Class II (US FDA UDI)

by Shoulder Options, Inc.

Identity

Trade Name: CRP™ Cuff Repair Plate System FDA UDI
Generic Name: Orthopaedic bone wire FDA UDI
Device Name: 1.6 x 150mm K-Wire, trocar tip FDA UDI
Model / Reference: 16-IN-KW150 FDA UDI
Description: 1.6 x 150mm K-Wire, trocar tip FDA UDI

Identifiers

Catalog Number: 16-IN-KW150 FDA UDI
Primary DI / UDI-DI: 00815482020138 FDA UDI
FDA Product Code: MBI FDA UDI
GMDN Term: Orthopaedic bone wire FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3040 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

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

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

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: Orthopaedic bone wire

CRP™ Cuff Repair Plate System by Shoulder Options, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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De Soutter Medical — De Soutter Medical, Ltd. · Class I
SMOOTH K-WIRE, DOUBLE END TROCAR POINT — Biomet Orthopedics, Inc. · Class II
mahe medical GmbH — mahe medical gmbh · Class II
OIC Variable Angle Small Fragment Locking Plate System — ORTHOPAEDIC IMPLANT COMPANY, THE · Class II
THP™ Hip Fracture Plating System — Biomet Orthopedics, Inc. · Class II
gSource — GSOURCE, LLC. · Class II

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 II	Pending data

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Manufacturer

Manufacturer: Shoulder Options, Inc.

Sources (1)

FDA UDI b48df63e-fed8-4117-8261-5f74367963b4 35 fields · synced Jun 8, 2026