Ambler Surgical

FDA UDI

Class I (US FDA UDI)

by Ambler Surgical, LLC

Identity

Trade Name: Ambler Surgical FDA UDI
Generic Name: Corneoscleral punch FDA UDI
Device Name: Iowa P.K. press punch, used for precise donor corneal button punching, designed for use with Ambler long trephines (33-0600 to 33-1200), includes two cutting blocks (Ambler # 7246E) FDA UDI
Model / Reference: Iowa P.K. press punch FDA UDI
Description: Iowa P.K. press punch, used for precise donor corneal button punching, designed for use with Ambler long trephines (33-0600 to 33-1200), includes two cutting blocks (Ambler # 7246E) FDA UDI

Identifiers

Catalog Number: 7245E FDA UDI
Primary DI / UDI-DI: 00190660128241 FDA UDI
FDA Product Code: HNJ FDA UDI
GMDN Term: Corneoscleral punch 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

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

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Lot / Batch Number

Yes

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Serial Number

FDA UDI

Expiration Date

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Manufacturing Date

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Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Corneoscleral punch

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

Similar devices

Also classified as Corneoscleral punch.

MILLENNIUM — AVALIGN TECHNOLOGIES, Inc. · Class I
Corneal Trephine Blade Ø 8.5 mm Stainless Steel — SURTEX INSTRUMENTS LTD · Class I
Punches — AURORA SURGICAL, LLC · Class I
ASELTECH — Asel Tibbi Aletler A.S. · Class I
Stephens Instruments — KRISHNA IMPORTS INC · Class I
Wexler Surgical, Inc. — Wexler Surgical, Inc. · Class I
ATLAS — ATLAS CERRAHİ ALETLER LTD. ŞTİ. · Class I
V. Mueller — STERIS CORPORATION · 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

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Manufacturer

Manufacturer: Ambler Surgical, LLC

Sources (1)

FDA UDI b9f8a830-a22b-4838-83e6-bb8aa91f41fc 35 fields · synced May 30, 2026