Ambler Surgical

FDA UDI

Class I (US FDA UDI)

by Ambler Surgical, LLC

Identity

Trade Name: Ambler Surgical FDA UDI
Generic Name: Intraocular retractor, single-use FDA UDI
Device Name: Iris retractors, round, light brown, flexible nylon fiber, stab knife included, horizontally packaged, sterile, disposable, 1 pack of 5 retractors FDA UDI
Model / Reference: Iris retractors FDA UDI
Description: Iris retractors, round, light brown, flexible nylon fiber, stab knife included, horizontally packaged, sterile, disposable, 1 pack of 5 retractors FDA UDI

Identifiers

Catalog Number: 5161E FDA UDI
Primary DI / UDI-DI: 00190660197186 FDA UDI
FDA Product Code: HNI FDA UDI
GMDN Term: Intraocular retractor, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 886.4350 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Intraocular retractor, single-use

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 26bc7e30-915c-47bf-9bc7-de30e6c4186a 35 fields · synced Jun 7, 2026