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Orthopedic Manual Surgical Instrument

FDA UDI

Class I (US FDA UDI)

by Fx Solutions

Identity

Trade Name
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT FDA UDI
Generic Name
Orthopaedic surgical procedure kit, non-medicated, reusable FDA UDI
Device Name
TRIAL HUMERAL CUP ECCENTRIC SYMMETRIC STANDARD Ø40+6 / TAPER Ø10 FDA UDI
Model / Reference
924-0806 FDA UDI
Description
TRIAL HUMERAL CUP ECCENTRIC SYMMETRIC STANDARD Ø40+6 / TAPER Ø10 FDA UDI

Identifiers

Catalog Number
924-0806 FDA UDI
Primary DI / UDI-DI
03701037306918 FDA UDI
FDA Product Code
LXH FDA UDI
GMDN Term
Orthopaedic surgical procedure kit, non-medicated, 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

No

FDA UDI

Single Use

No

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

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: Orthopaedic surgical procedure kit, non-medicated, reusable

Orthopedic Manual Surgical Instrument by Fx Solutions — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic surgical procedure kit, non-medicated, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Fx Solutions

Sources (1)

  • FDA UDI 5d31c49a-3719-43f6-a80c-c165d37292a1 34 fields · synced Jun 1, 2026