Identity
- Trade Name
- Beamer Plus CB200 FDA UDI
- Generic Name
- Inert gas-enhanced electrosurgical system generator FDA UDI
- Model / Reference
- CB200 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04057607000113 FDA UDI
- 510(k) Number
- K081678 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Inert gas-enhanced electrosurgical system generator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Inert gas-enhanced electrosurgical system generator
Beamer Plus CB200 by KLS Martin GmbH + Co. KG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K081678 also covers:
- Beamer Cart CC200 — KLS Martin GmbH + Co. KG
- Beamer ESU CE200 — KLS Martin GmbH + Co. KG
- Connecting Cable for Argon Probes — KLS Martin GmbH + Co. KG
- Double Pedal Foot Switch — KLS Martin GmbH + Co. KG
- Double Pedal Foot Switch — KLS Martin GmbH + Co. KG
- Pressure Reducer CGA 580 — KLS Martin GmbH + Co. KG
- Reusable Cable for Neutral Electrodes — KLS Martin GmbH + Co. KG
- Single Pedal Foot Switch — KLS Martin GmbH + Co. KG
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
- KLS Martin GmbH + Co. KG
Sources (1)
- FDA UDI 908c5956-a051-49c0-985b-6732e27d67f1 33 fields · synced May 31, 2026