Ambler Surgical

FDA UDI

Class I (US FDA UDI)

by Ambler Surgical, LLC

Identity

Trade Name: Ambler Surgical FDA UDI
Generic Name: Nerve/vessel retractor FDA UDI
Device Name: Frazier skin hook , 7'', 1 blunt prong, 2.5mm wide, flat handle FDA UDI
Model / Reference: Frazier skin hook FDA UDI
Description: Frazier skin hook , 7'', 1 blunt prong, 2.5mm wide, flat handle FDA UDI

Identifiers

Catalog Number: 37-424 FDA UDI
Primary DI / UDI-DI: 00190660084370 FDA UDI
FDA Product Code: GDG FDA UDI
GMDN Term: Nerve/vessel retractor FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4800 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

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: Nerve/vessel retractor

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

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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 c9e3be1d-eb44-443f-b4e1-c7844daa4ef1 35 fields · synced Jun 8, 2026