Ambler Surgical

FDA UDI

Class I (US FDA UDI)

by Ambler Surgical, LLC

Identity

Trade Name: Ambler Surgical FDA UDI
Generic Name: Ophthalmic knife, single-use FDA UDI
Device Name: Slit knife, 2.5mm wide, angled double-bevel symmetry blade, full handle knife, round stock, packaged individually, sterile, disposable, box of 6 FDA UDI
Model / Reference: Slit knife FDA UDI
Description: Slit knife, 2.5mm wide, angled double-bevel symmetry blade, full handle knife, round stock, packaged individually, sterile, disposable, box of 6 FDA UDI

Identifiers

Catalog Number: 962568 FDA UDI
Primary DI / UDI-DI: 10190660200081 FDA UDI
FDA Product Code: HNN FDA UDI
GMDN Term: Ophthalmic knife, 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: Ophthalmic knife, 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 e909ce8a-8741-4a03-ac9d-665f30a7ad93 35 fields · synced May 30, 2026