Ambler Surgical

FDA UDI

Class I (US FDA UDI)

by Ambler Surgical, LLC

Identity

Trade Name: Ambler Surgical FDA UDI
Generic Name: Eyelid speculum, reusable FDA UDI
Device Name: Williams lid speculum, 3 3/8'', adult size, 14.0mm closed wire blades, 52.0mm blade spread, nasal approach, screw-type locking mechanism FDA UDI
Model / Reference: Williams lid speculum FDA UDI
Description: Williams lid speculum, 3 3/8'', adult size, 14.0mm closed wire blades, 52.0mm blade spread, nasal approach, screw-type locking mechanism FDA UDI

Identifiers

Catalog Number: 7954E FDA UDI
Primary DI / UDI-DI: 00190660181390 FDA UDI
FDA Product Code: HNC FDA UDI
GMDN Term: Eyelid speculum, reusable 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

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: Eyelid speculum, reusable

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

Similar devices

Also classified as Eyelid speculum, reusable.

Sklar® — Sklar Corporation · Class I
Ophthalmic Speculum — AURORA SURGICAL, LLC · Class I
PILLING — TELEFLEX INCORPORATED · Class I
MSI Precision Specialty Instruments — Med Saver, Inc. · Class I
Walcott Rx Products — Walcott Rx Product Inc · Class I
MSI Precision Specialty Instruments — Med Saver, Inc. · Class I
COOK EYE SPECULUM — SONTEC INSTRUMENTS, INC. · Class I
Wire Speculum — SONTEC INSTRUMENTS, INC. · Class I

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

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

Manufacturer

Manufacturer: Ambler Surgical, LLC

Sources (1)

FDA UDI 68e52d78-3e17-47fb-bcce-62a2ea2d2d8c 35 fields · synced Jun 6, 2026