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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
Van-Buren urethral sound, 11'', curved, 32 French FDA UDI
Model / Reference
Van-Buren urethral sound FDA UDI
Description
Van-Buren urethral sound, 11'', curved, 32 French FDA UDI

Identifiers

Catalog Number
44-804 FDA UDI
Primary DI / UDI-DI
00190660031466 FDA UDI
FDA Product Code
FBS FDA UDI
GMDN Term
Urethral bougie, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
876.4590 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

No

FDA UDI

Manufacturing Date

No

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.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ambler Surgical, LLC

Sources (1)

  • FDA UDI 8678a23c-e017-4b71-90c3-f9a983d45272 35 fields · synced Jun 1, 2026