Global Unite

FDA UDI

Class II (US FDA UDI)

by Depuy (ireland)

Identity

Trade Name: GLOBAL UNITE FDA UDI
Generic Name: Stem-fixed metallic humeral head prosthesis FDA UDI
Device Name: GLOBAL UNITE STANDARD HUMERAL HEAD SIZE 44mm x 12mm FDA UDI
Model / Reference: 1100-44-530 FDA UDI
Description: GLOBAL UNITE STANDARD HUMERAL HEAD SIZE 44mm x 12mm FDA UDI

Identifiers

Catalog Number: 110044530 FDA UDI
Primary DI / UDI-DI: 10603295430575 FDA UDI
510(k) Number: K133834 FDA UDI
K170748 FDA UDI
FDA Product Code: KWS FDA UDI
HSD FDA UDI
GMDN Term: Stem-fixed metallic humeral head prosthesis FDA UDI

Classification

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

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Stem-fixed metallic humeral head prosthesis

Global Unite by Depuy (ireland) — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Stem-fixed metallic humeral head prosthesis.

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FLEX SHOULDER SYSTEM — TORNIER, INC. · Class II
FLEX SHOULDER SYSTEM — TORNIER, INC. · Class II
GLOBAL ADVANTAGE — DEPUY ORTHOPAEDICS, INC. · Class II
FLEX SHOULDER SYSTEM — TORNIER, INC. · Class II
PERFORM™ HUMERAL SYSTEM — TORNIER, INC. · Class II
Equinoxe — Exactech, Inc. · Class II
TORNIER PERFORM™ HUMERAL SYSTEM — TORNIER, INC. · Class II

Cleared under the same submission

K133834 also covers:

K170748 also covers:

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: Depuy (ireland)

Sources (1)

FDA UDI 5b533767-0214-4dc0-8a33-8e9cefea99dd 36 fields · synced May 30, 2026