Identity
- Trade Name
- Ambu® aScope™ 5 Cysto HD FDA UDI
- Generic Name
- Flexible video cystonephroscope, single-use FDA UDI
- Device Name
- Flexible Cysto-nephroscope, Standard Deflection FDA UDI
- Model / Reference
- 603101000 FDA UDI
- Description
- Flexible Cysto-nephroscope, Standard Deflection FDA UDI
Identifiers
- Catalog Number
- 603101000 FDA UDI
- Primary DI / UDI-DI
- 05707480164493 FDA UDI
- FDA Product Code
- FAJ FDA UDI
- GMDN Term
- Flexible video cystonephroscope, single-use 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
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
Yes
FDA UDI
Ethylene Oxide FDA UDI
Dimensions & Sizes
- Size
- Lumen/Inner Diameter — 2.2 Millimeter FDA UDIOuter Diameter — 6 Millimeter FDA UDI
Category: Flexible video cystonephroscope, single-use
Ambu® aScope™ 5 Cysto HD by Ambu A/S — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Flexible video cystonephroscope, single-use.
- Ambu® aScope™ 5 Cysto HD — Ambu A/S · Class II
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
- Ambu A/S
Sources (1)
- FDA UDI 50a3aa5d-f15d-48c0-9564-2345ed90cefb 37 fields · synced Jun 1, 2026