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CSR Shoulder System

FDA UDI

Class II (US FDA UDI)

by CATALYST ORTHOSCIENCE Inc

Identity

Trade Name
CSR Shoulder System FDA UDI
Generic Name
Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI
Device Name
Small Humeral Cover FDA UDI
Model / Reference
1226-4117 FDA UDI
Description
Small Humeral Cover FDA UDI

Identifiers

Primary DI / UDI-DI
00811596030193 FDA UDI
510(k) Number
K152825 FDA UDI
FDA Product Code
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
888.3650 FDA UDI
888.3690 FDA UDI
Commercial Distribution
Not 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

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

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

CSR Shoulder System by CATALYST ORTHOSCIENCE Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K152825 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
CATALYST ORTHOSCIENCE Inc

Sources (1)

  • FDA UDI 42ae43ab-f3c3-402c-93cb-40477d69256f 37 fields · synced May 31, 2026