Identity
- Trade Name
- Resectoscopy bridge FDA UDI
- Generic Name
- Laser beam delivery unit holder FDA UDI
- Model / Reference
- 199 075 030BC FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04059082010885 FDA UDI
- 510(k) Number
- K971881 FDA UDI
- FDA Product Code
- FDC FDA UDI
- GMDN Term
- Laser beam delivery unit holder FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 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
No
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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Laser beam delivery unit holder
Resectoscopy bridge by SOPRO-COMEG GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Laser beam delivery unit holder.
- INTRALASE TECHNOLOGY PI — Johnson & Johnson Surgical Vision, Inc. · Class II
- ML 830® — MICROLIGHT CORPORATION OF AMERICA · Class II
- FS DISPOSABLE INTERFACE — Johnson & Johnson Surgical Vision, Inc. · Class I
- FLEX — Medrobotics Corporation · Class II
- FS DISPOSABLE INTERFACE — Johnson & Johnson Surgical Vision, Inc. · Class I
- INTRALASE TECHNOLOGY PI — Johnson & Johnson Surgical Vision, Inc. · Class II
- Flex — Medrobotics Corporation · Class II
- Resectoscopy bridge — SOPRO-COMEG GmbH · Class II
Cleared under the same submission
K971881 also covers:
- Bipolar HF cable — SOPRO-COMEG GmbH
- Bipolar HF cable — SOPRO-COMEG GmbH
- Bipolar HF cable — SOPRO-COMEG GmbH
- Electrode — SOPRO-COMEG GmbH
- Electrode — SOPRO-COMEG GmbH
- Electrode — SOPRO-COMEG GmbH
- Electrode — SOPRO-COMEG GmbH
- Electrode — SOPRO-COMEG GmbH
- Electrode — SOPRO-COMEG GmbH
- Electrode — SOPRO-COMEG GmbH
- Electrode — SOPRO-COMEG GmbH
- Electrode — SOPRO-COMEG GmbH
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- SOPRO-COMEG GmbH
Sources (1)
- FDA UDI 63ed0850-0e20-4645-95f0-15cfe189d92e 33 fields · synced May 30, 2026