Ambler Value Line

FDA UDI

Class I (US FDA UDI)

by Ambler Surgical, LLC

Identity

Trade Name: Ambler Value Line FDA UDI
Generic Name: Eyelid speculum, reusable FDA UDI
Device Name: Berke-Jaeger lid plate, 4 3/8'', double-ended, 20.0mm and 23.0mm blades, economy pattern recommended for clinics/mission trips only FDA UDI
Model / Reference: Berke-Jaeger lid plate FDA UDI
Description: Berke-Jaeger lid plate, 4 3/8'', double-ended, 20.0mm and 23.0mm blades, economy pattern recommended for clinics/mission trips only FDA UDI

Identifiers

Catalog Number: EC5260 FDA UDI
Primary DI / UDI-DI: 00190660196790 FDA UDI
FDA Product Code: HNI 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 Value Line 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 f09cbaf2-d632-4b34-a2e8-0ee7f7d07828 35 fields · synced May 30, 2026