Identity
- Trade Name
- Sustainable Technologies FDA UDI
- Generic Name
- Arthroscopic shaver system blade, reprocessed FDA UDI
- Device Name
- CoolCut Sabre Shaver Blade, small hub (green) FDA UDI
- Model / Reference
- ST-AR-9200SR FDA UDI
- Description
- CoolCut Sabre Shaver Blade, small hub (green) FDA UDI
Identifiers
- Catalog Number
- ST-AR-9200SR FDA UDI
- Primary DI / UDI-DI
- 00810041639981 FDA UDI
- 510(k) Number
- K172092 FDA UDI
- FDA Product Code
- HRX FDA UDI
- GMDN Term
- Arthroscopic shaver system blade, reprocessed FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.1100 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Arthroscopic shaver system blade, reprocessed
A comprehensive medical device directory, providing detailed information on the CoolCut Sabre Shaver Blade, a cutting device designed for use in an arthroscopic shaver system. The device is designed for orthopedic surgery and has been previously used as a single-use item, but has now undergone reprocessing.
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Cleared under the same submission
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
- Provision
Sources (1)
- FDA UDI 49dae798-994d-4820-bf68-67ca9be9d10e 36 fields · synced Jul 26, 2026