Identity
- Trade Name
- AWC FDA UDI
- Generic Name
- Endoscope channel support kit FDA UDI
- Device Name
- The AWC is an additional working channel for flexible endoscopes • external channel for insertion of instruments or flushing and suction • it consists of: distal attachment (cap) | shaft | adaptor for fixation at the endoscope handle | sleeve | valve and Luer Lock connection | tapes for fixation • for gastroscopes with insertion length of 103 - 110 cm FDA UDI
- Model / Reference
- 122 cm FDA UDI
- Description
- The AWC is an additional working channel for flexible endoscopes • external channel for insertion of instruments or flushing and suction • it consists of: distal attachment (cap) | shaft | adaptor for fixation at the endoscope handle | sleeve | valve and Luer Lock connection | tapes for fixation • for gastroscopes with insertion length of 103 - 110 cm FDA UDI
Identifiers
- Catalog Number
- 200.57.01 FDA UDI
- Primary DI / UDI-DI
- 04260206310952 FDA UDI
- FDA Product Code
- FZX FDA UDI
- GMDN Term
- Endoscope channel support kit FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Commercial Distribution
- 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Endoscope channel support kit
Awc by Ovesco Endoscopy AG — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 I | Pending data |
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Manufacturer
- Manufacturer
- Ovesco Endoscopy AG
Sources (1)
- FDA UDI 9b50658a-50be-4ecc-b542-43d1a7da4430 36 fields · synced Jun 8, 2026