Identity
- Trade Name
- CS-SR10-00 OpClear Disposable FDA UDI
- Generic Name
- Surgical irrigation pump FDA UDI
- Device Name
- The OpClear Disposable is a 10mm x00degree x 328mm (L) sterile, invasive, single use accessory to the OpClear Control Unit which is fitted to a compatible laparoscope. FDA UDI
- Model / Reference
- CS-SR10-00 FDA UDI
- Description
- The OpClear Disposable is a 10mm x00degree x 328mm (L) sterile, invasive, single use accessory to the OpClear Control Unit which is fitted to a compatible laparoscope. FDA UDI
Identifiers
- Catalog Number
- CS-SR10-00 FDA UDI
- Primary DI / UDI-DI
- 50603468007076 FDA UDI
- 510(k) Number
- K171637 FDA UDI
- FDA Product Code
- FEQ FDA UDIOCX FDA UDI
- GMDN Term
- Surgical irrigation pump FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Commercial Distribution
- Not 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
No
FDA UDI
CS-SR10-00 OpClear Disposable by Cipher Surgical, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Cipher Surgical, Ltd.
Sources (1)
- FDA UDI 07242ab6-b0e8-4730-83b0-02a94e218c9a 38 fields · synced May 30, 2026