Identity
- Trade Name
- Coloplast FDA UDI
- Generic Name
- Urogenital surgical laser system beam guide, reusable FDA UDI
- Device Name
- SabreLine Reusable Laser Fiber 940um FDA UDI
- Model / Reference
- RUS940 FDA UDI
- Description
- SabreLine Reusable Laser Fiber 940um FDA UDI
Identifiers
- Catalog Number
- RUS940 FDA UDI
- Primary DI / UDI-DI
- 05708932688543 FDA UDI
- 510(k) Number
- K182831 FDA UDI
- FDA Product Code
- GEX FDA UDI
- GMDN Term
- Urogenital surgical laser system beam guide, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4810 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 940 Micrometer FDA UDI
Category: Urogenital surgical laser system beam guide, reusable
Coloplast by Coloplast A/S — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Coloplast A/S
Sources (1)
- FDA UDI f9b51bfb-9ff2-4af2-a043-8df06656fd95 38 fields · synced May 30, 2026