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U-Wise Hip Surgical Guide Template

FDA UDI

Class I (US FDA UDI)

by United Orthopedic Corp.

Identity

Trade Name
U-Wise Hip Surgical Guide Template FDA UDI
Generic Name
Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI
Device Name
Positioning offset guide, 45mm FDA UDI
Model / Reference
9206-5081 FDA UDI
Description
Positioning offset guide, 45mm FDA UDI

Identifiers

Catalog Number
9206-5081 FDA UDI
Primary DI / UDI-DI
04719886894059 FDA UDI
FDA Product Code
LXH FDA UDI
GMDN Term
Orthopaedic prosthesis implantation positioning instrument, 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

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Orthopaedic prosthesis implantation positioning instrument, reusable

U-Wise Hip Surgical Guide Template by United Orthopedic Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic prosthesis implantation positioning instrument, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
United Orthopedic Corp.

Sources (1)

  • FDA UDI f8321c03-2a87-4196-bc7e-7020cc27cdd5 35 fields · synced Jun 8, 2026