Ambler Surgical

FDA UDI

Class I (US FDA UDI)

by Ambler Surgical, LLC

Identity

Trade Name: Ambler Surgical FDA UDI
Generic Name: Urethral bougie, reusable FDA UDI
Device Name: Bakes common bile duct dilators, 9'', set of 9, sizes 3.0mm - 11.0mm (43-903, 43-904. 43-905. 43-906, 43-907, 43-908, 43-909, 43-910 and 43-911) FDA UDI
Model / Reference: Bakes common bile duct dilators FDA UDI
Description: Bakes common bile duct dilators, 9'', set of 9, sizes 3.0mm - 11.0mm (43-903, 43-904. 43-905. 43-906, 43-907, 43-908, 43-909, 43-910 and 43-911) FDA UDI

Identifiers

Catalog Number: 43-915 FDA UDI
Primary DI / UDI-DI: 00190660029500 FDA UDI
FDA Product Code: FFP FDA UDI
GMDN Term: Urethral bougie, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 876.5450 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Urethral bougie, reusable

Ambler Surgical by Ambler Surgical, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Urethral bougie, reusable.

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Medicon — Medicon eG. Chirurgiemechaniker-Genossenschaft · Class I
Dilation set — SOPRO-COMEG GmbH · Class II
Medicon — Medicon eG. Chirurgiemechaniker-Genossenschaft · Class I
Medicon — Medicon eG. Chirurgiemechaniker-Genossenschaft · Class I
American Medicals — AMERICAN MEDICALS · Class I
Novo Surgical Inc. — NOVO SURGICAL, INC. · Class I

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: Ambler Surgical, LLC

Sources (1)

FDA UDI e9cc9774-27ba-46f9-a45e-aadec27f65df 35 fields · synced May 31, 2026