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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
Otologic clamp FDA UDI
Device Name
Derlacki ossicle holding clamp, 4 3/4'', 1.0mm teeth, 1.5mm x 4.0mm vertical groove, 1.5mm x 2.0mm horizontal groove, flat handle, screw lock FDA UDI
Model / Reference
Derlacki ossicle holding clamp FDA UDI
Description
Derlacki ossicle holding clamp, 4 3/4'', 1.0mm teeth, 1.5mm x 4.0mm vertical groove, 1.5mm x 2.0mm horizontal groove, flat handle, screw lock FDA UDI

Identifiers

Catalog Number
18-265 FDA UDI
Primary DI / UDI-DI
00190660014919 FDA UDI
FDA Product Code
JYF FDA UDI
GMDN Term
Otologic clamp FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
874.4420 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: Otologic clamp

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

Similar devices

Also classified as Otologic clamp.

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 01f716bd-69dc-409a-bbfe-a12af12b1b1a 35 fields · synced May 30, 2026