Ambler Surgical

FDA UDI

Class I (US FDA UDI)

by Ambler Surgical, LLC

Identity

Trade Name: Ambler Surgical FDA UDI
Generic Name: Ocular hook/spatula/manipulator, reusable FDA UDI
Device Name: Machat PRK/LASIK spatula, 4 3/4'', angled, 2.0mm x 5.0mm semi-sharp blade, round handle FDA UDI
Model / Reference: Machat PRK/LASIK spatula FDA UDI
Description: Machat PRK/LASIK spatula, 4 3/4'', angled, 2.0mm x 5.0mm semi-sharp blade, round handle FDA UDI

Identifiers

Catalog Number: 6838E FDA UDI
Primary DI / UDI-DI: 00190660175610 FDA UDI
FDA Product Code: HND FDA UDI
GMDN Term: Ocular hook/spatula/manipulator, 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: Ocular hook/spatula/manipulator, reusable

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

Similar devices

Also classified as Ocular hook/spatula/manipulator, reusable.

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57150 Spatula, Model Giessen — Bausch & Lomb GmbH · Class I
Diamatrix — Diamatrix · Class I
Rumex — Rumex International Co. · Class I
Ophthalmic Spatula — CILITA Ltd. · Class I
Rumex — Rumex International Co. · Class I
Sklar — Sklar Corporation · Class I
Surgical Direct — SURGICAL DIRECT, 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

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Manufacturer

Manufacturer: Ambler Surgical, LLC

Sources (1)

FDA UDI 70f23b37-7564-4b19-8db1-207f092684e1 35 fields · synced Jun 1, 2026