33cm Laparoscopic Narrow Curved Blade +2 more models
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- 33cm Laparoscopic Narrow Curved Blade; Blue PTFE; Black Insulation FDA UDI
- Generic Name
- Open-surgery electrosurgical electrode, monopolar, single-use FDA UDI
- Model / Reference
- 20155ACT FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00787551002911 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Open-surgery electrosurgical electrode, monopolar, single-use FDA UDI
- Models / Variants
- Blue PTFE FDA UDIBlack Insulation 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
Single Use
Yes
Implantable
No
Contains Latex
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
Yes
Expiration Date
No
Manufacturing Date
No
Category: Open-surgery electrosurgical electrode, monopolar, single-use
This 33cm laparoscopic narrow curved blade; blue PTFE; black insulation medical device is designed for general surgical procedures. It features a single-use design, is MR Safe, and has been certified by [map[id:00787551002911 issuing_agency:GS1 type:Primary] GS1. The device is in commercial distribution and was last updated on 2023-01-06. Please note that it is intended for implantable use and requires a patient contact return electrode to complete the circuit.
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Authorization Coverage (1 country)
Regulatory Authorizations
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
- Xodus Medical, Inc.
Sources (1)
- FDA UDI e94a1287-1ae9-495d-8feb-d7ed4a43b5e3 33 fields · synced Jul 29, 2026