← Back to catalogue

Ambler Surgical

FDA UDI

Class I (US FDA UDI)

by Ambler Surgical, LLC

Identity

Trade Name
Ambler Surgical FDA UDI
Generic Name
Self-retaining ear speculum FDA UDI
Device Name
Bruening aural magnifier, complete set includes - 4 speculum and rubber bulb in a case FDA UDI
Model / Reference
Bruening aural magnifier FDA UDI
Description
Bruening aural magnifier, complete set includes - 4 speculum and rubber bulb in a case FDA UDI

Identifiers

Catalog Number
43-820 FDA UDI
Primary DI / UDI-DI
00190660106270 FDA UDI
FDA Product Code
EPY FDA UDI
GMDN Term
Self-retaining ear speculum FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.1800 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

Yes

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: Self-retaining ear speculum

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

Similar devices

Also classified as Self-retaining ear speculum.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Ambler Surgical, LLC

Sources (1)

  • FDA UDI ef6e83b7-befc-410e-a744-51c79dd1305e 35 fields · synced Jun 6, 2026