Exeter

FDA UDI

Class II (US FDA UDI)

by Howmedica Osteonics Corp.

Identity

Trade Name: EXETER FDA UDI
Generic Name: Uncoated hip femur prosthesis, modular FDA UDI
Device Name: EXETER STEM V40 FDA UDI
Model / Reference: 0580-3-321 FDA UDI
Description: EXETER STEM V40 FDA UDI

Identifiers

Catalog Number: 0580-3-321 FDA UDI
Primary DI / UDI-DI: 07613327123753 FDA UDI
FDA Product Code: KWY FDA UDI
JDG FDA UDI
LZO FDA UDI
JDI FDA UDI
GMDN Term: Uncoated hip femur prosthesis, modular FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3390 FDA UDI
888.3360 FDA UDI
888.3353 FDA UDI
888.3350 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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

FDA UDI

MRI Safety

MR Conditional FDA UDI

Dimensions & Sizes

Size: Length — 205.0 Millimeter FDA UDI

Category: Uncoated hip femur prosthesis, modular

Exeter by Howmedica Osteonics Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Howmedica Osteonics Corp.

Sources (1)

FDA UDI 7ecdcc2b-f757-4c97-838b-e5d87df58926 35 fields · synced May 30, 2026