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Glenoid template Ø46

FDA UDI

Class II (US FDA UDI)

by Fournitures Hospitalieres Industrie

Identity

Trade Name
Glenoid template Ø46 FDA UDI
Generic Name
Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI
Model / Reference
261078 FDA UDI

Identifiers

Primary DI / UDI-DI
03661489610783 FDA UDI
510(k) Number
K093599 FDA UDI
FDA Product Code
KWS FDA UDI
KWT FDA UDI
HSD FDA UDI
GMDN Term
Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3660 FDA UDI
888.3650 FDA UDI
888.3690 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

No

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

No

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

Glenoid template Ø46 by Fournitures Hospitalieres Industrie — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic prosthesis implantation positioning instrument, reusable.

Cleared under the same submission

K093599 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Fournitures Hospitalieres Industrie

Sources (1)

  • FDA UDI 7b75851a-819a-421e-8e06-b0f894da1c07 33 fields · synced Jun 1, 2026