Ambler Value Line

FDA UDI

Class I (US FDA UDI)

by Ambler Surgical, LLC

Identity

Trade Name: Ambler Value Line FDA UDI
Generic Name: Enucleation scissors, reusable FDA UDI
Device Name: Lewis lens loop, 5 3/8'', small 5.0mm x 6.0mm smooth loop, flat handle, economy pattern recommended for clinics/mission trips only FDA UDI
Model / Reference: Lewis lens loop FDA UDI
Description: Lewis lens loop, 5 3/8'', small 5.0mm x 6.0mm smooth loop, flat handle, economy pattern recommended for clinics/mission trips only FDA UDI

Identifiers

Catalog Number: EC3725 FDA UDI
Primary DI / UDI-DI: 00190660196684 FDA UDI
FDA Product Code: HNE FDA UDI
GMDN Term: Enucleation scissors, 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: Enucleation scissors, 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 e6e040cc-098e-4df8-8b89-50c5ba70e0e2 35 fields · synced Jun 1, 2026