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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
Wire cutter FDA UDI
Device Name
Wire cutter, 6'', straight jaws, cuts up to 0.062'' (1.5mm) soft wire and 0.031'' (1.0mm) hard wire FDA UDI
Model / Reference
Wire cutter FDA UDI
Description
Wire cutter, 6'', straight jaws, cuts up to 0.062'' (1.5mm) soft wire and 0.031'' (1.0mm) hard wire FDA UDI

Identifiers

Catalog Number
43-658 FDA UDI
Primary DI / UDI-DI
00190660026783 FDA UDI
FDA Product Code
HXZ FDA UDI
GMDN Term
Wire cutter FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
888.4540 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: Wire cutter

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

Similar devices

Also classified as Wire cutter.

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 aeb9f1d0-b9ac-4161-aeda-e3bd1f7e2284 35 fields · synced May 30, 2026