Identity
- Trade Name
- aScope™ 4 RhinoLaryngo Intervention FDA UDI
- Generic Name
- Flexible video otorhinolaryngoscope, single-use FDA UDI
- Device Name
- Ambu aScope 4 RhinoLaryngo Intervention Single-use, flexible Rhinolaryngoscope Sterile from package. 2.2 mm working channel, outer diameter 5.0 mm, lenght of 350 mm. and a 130-degree bending angle. Minimum purchase 5 pcs = 1 box FDA UDI
- Model / Reference
- 512001000 FDA UDI
- Description
- Ambu aScope 4 RhinoLaryngo Intervention Single-use, flexible Rhinolaryngoscope Sterile from package. 2.2 mm working channel, outer diameter 5.0 mm, lenght of 350 mm. and a 130-degree bending angle. Minimum purchase 5 pcs = 1 box FDA UDI
Identifiers
- Catalog Number
- 512001000 FDA UDI
- Primary DI / UDI-DI
- 05707480136971 FDA UDI
- FDA Product Code
- EOB FDA UDI
- GMDN Term
- Flexible video otorhinolaryngoscope, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.4760 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
No
FDA UDI
Dimensions & Sizes
- Size
- Lumen/Inner Diameter — 2 Millimeter FDA UDIOuter Diameter — 5 Millimeter FDA UDILength — 350 Millimeter FDA UDI
Category: Flexible video otorhinolaryngoscope, single-use
aScope™ 4 RhinoLaryngo Intervention by Ambu A/S — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Flexible video otorhinolaryngoscope, single-use.
- Single-Use Flexible Rhinolaryngoscope — Hunan Vathin Medical Instrument Co., Ltd · Class II
- Single-Use Flexible Rhinolaryngoscope — Hunan Vathin Medical Instrument Co., Ltd · Class II
- Single-Use Flexible Rhinolaryngoscope — Hunan Vathin Medical Instrument Co., Ltd · Class II
- Single-Use Flexible Rhinolaryngoscope — Hunan Vathin Medical Instrument Co., Ltd · Class II
- Single-Use Rhinolaryngoscope — Shenzhen HugeMed Medical Technical Development Co., Ltd. · Class II
- Single-Use Flexible Rhinolaryngoscope — Hunan Vathin Medical Instrument Co., Ltd · Class II
- Single-Use Flexible Rhinolaryngoscope — HUNAN VATHIN MEDICAL INSTRUMENT CO., LTD. · Class II
- Peregrine drivable ENT scope — 3nt Medical , Ltd. · 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 86b0853f-ae0b-4232-93e4-4ae813d9068a 37 fields · synced May 30, 2026