Identity
- Trade Name
- Catalyst CSR Shoulder System FDA UDI
- Generic Name
- Instrument tray, reusable FDA UDI
- Device Name
- Lid FDA UDI
- Model / Reference
- 1226-3003 FDA UDI
- Description
- Lid FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00851388006159 FDA UDI
- 510(k) Number
- K152825 FDA UDI
- FDA Product Code
- HSD FDA UDIKWT FDA UDI
- GMDN Term
- Instrument tray, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3690 FDA UDI888.3650 FDA UDI
- Commercial Distribution
- 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
Moist Heat or Steam Sterilization FDA UDI
Category: Instrument tray, reusable
Catalyst CSR Shoulder System by CATALYST ORTHOSCIENCE Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Instrument tray, reusable.
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- Instrument Case — Katena Products, Inc. · Class I
- Hu-Friedy — Hu-Friedy Manufacturing Co., LLC · Class I
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- SHEFFIELD RING FIXATOR — Orthofix, Inc. · Class II
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Cleared under the same submission
K152825 also covers:
- CSR Shoulder System — CATALYST ORTHOSCIENCE Inc
- CSR Shoulder System — CATALYST ORTHOSCIENCE Inc
- CSR Shoulder System — CATALYST ORTHOSCIENCE Inc
- CSR Shoulder System — CATALYST ORTHOSCIENCE Inc
- Catalyst CSR Shoulder System — CATALYST ORTHOSCIENCE Inc
- Catalyst CSR Shoulder System — CATALYST ORTHOSCIENCE Inc
- Catalyst CSR Shoulder System — CATALYST ORTHOSCIENCE Inc
- Catalyst CSR Shoulder System — CATALYST ORTHOSCIENCE Inc
- Catalyst CSR Shoulder System — CATALYST ORTHOSCIENCE Inc
- Catalyst CSR Shoulder System — CATALYST ORTHOSCIENCE Inc
- Catalyst CSR Shoulder System — CATALYST ORTHOSCIENCE Inc
- Catalyst CSR Shoulder System — CATALYST ORTHOSCIENCE Inc
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
- CATALYST ORTHOSCIENCE Inc
Sources (1)
- FDA UDI 2773fd35-b0be-48b8-829e-147cd5f5452c 36 fields · synced May 30, 2026