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Ambu

FDA UDI

Class II (US FDA UDI)

by Bosma Enterprises

Identity

Trade Name
Ambu FDA UDI
Generic Name
Flexible video cystoscope, single-use FDA UDI
Device Name
Ambu aScope 4 Cysto Reverse Deflection 5/Box FDA UDI
Model / Reference
10-600177-1 FDA UDI
Description
Ambu aScope 4 Cysto Reverse Deflection 5/Box FDA UDI

Identifiers

Catalog Number
10-600177-1 FDA UDI
Primary DI / UDI-DI
10818634025194 FDA UDI
FDA Product Code
FAJ FDA UDI
GMDN Term
Flexible video cystoscope, 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

No

FDA UDI

Dimensions & Sizes

Size
Lumen/Inner Diameter — 2.2 Millimeter FDA UDI
Outer Diameter — 6.0 Millimeter FDA UDI

Category: Flexible video cystoscope, single-use

Ambu by Bosma Enterprises — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Flexible video cystoscope, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Bosma Enterprises

Sources (1)

  • FDA UDI 6f645557-8335-4182-9c1d-3a19bdf3e88d 37 fields · synced May 30, 2026