Inhance Shoulder System

FDA UDI

Class I (US FDA UDI)

by Depuy (ireland)

Identity

Trade Name: INHANCE SHOULDER SYSTEM FDA UDI
Generic Name: Joint prosthesis implantation kit, single-use FDA UDI
Device Name: INHANCE SHOULDER SYSTEM GLENOID PREP KIT MEDIUM NA FDA UDI
Model / Reference: 7701-10-400 FDA UDI
Description: INHANCE SHOULDER SYSTEM GLENOID PREP KIT MEDIUM NA FDA UDI

Identifiers

Catalog Number: 770110400 FDA UDI
Primary DI / UDI-DI: 10603295551850 FDA UDI
FDA Product Code: KIJ FDA UDI
HTO FDA UDI
HWT FDA UDI
GMDN Term: Joint prosthesis implantation kit, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4820 FDA UDI
888.4540 FDA UDI
888.4800 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Joint prosthesis implantation kit, single-use

Inhance Shoulder System by Depuy (ireland) — Class I — 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 I	Pending data

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Manufacturer

Manufacturer: Depuy (ireland)

Sources (1)

FDA UDI e55fda10-6e0f-404d-b7fd-5a406fd952ee 35 fields · synced May 30, 2026