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Global Unite

FDA UDI

Class II (US FDA UDI)

by Depuy (ireland)

Identity

Trade Name
GLOBAL UNITE FDA UDI
Generic Name
Shoulder humeral body prosthesis FDA UDI
Device Name
GLOBAL UNITE ANATOMIC PROXIMAL BODY 135 DEGREE SIZE 14 POROCOAT FDA UDI
Model / Reference
1100-50-000 FDA UDI
Description
GLOBAL UNITE ANATOMIC PROXIMAL BODY 135 DEGREE SIZE 14 POROCOAT FDA UDI

Identifiers

Catalog Number
110050000 FDA UDI
Primary DI / UDI-DI
10603295004639 FDA UDI
510(k) Number
K133834 FDA UDI
K170748 FDA UDI
FDA Product Code
KWS FDA UDI
HSD FDA UDI
GMDN Term
Shoulder humeral body 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

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: Shoulder humeral body prosthesis

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

Similar devices

Also classified as Shoulder humeral body prosthesis.

Cleared under the same submission

K133834 also covers:

K170748 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Depuy (ireland)

Sources (1)

  • FDA UDI 46f008ad-5335-4ef5-bce3-f59694c88864 36 fields · synced May 30, 2026