Ambler Surgical

FDA UDI

Class II (US FDA UDI)

by Ambler Surgical, LLC

Identity

Trade Name: Ambler Surgical FDA UDI
Generic Name: Ophthalmic conformer FDA UDI
Device Name: Bilateral oval conformer, made of PMMA plastic, small, with holes, packaged individually, non-sterile, box of 1 FDA UDI
Model / Reference: 9047E FDA UDI
Description: Bilateral oval conformer, made of PMMA plastic, small, with holes, packaged individually, non-sterile, box of 1 FDA UDI

Identifiers

Catalog Number: 9047E FDA UDI
Primary DI / UDI-DI: 00190660018924 FDA UDI
FDA Product Code: HQN FDA UDI
GMDN Term: Ophthalmic conformer FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 886.3130 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

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

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Ophthalmic conformer

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

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Small Conformer (non-sterile) — Gulden Ophthalmics · Class II
Bio-Eye® — INTEGRATED ORBITAL IMPLANTS, INC. · Class II
Silicone Conformer — JARDON EYE PROSTHETICS, INC. · Class II
PROKERA® — BioTissue Holdings Inc. · Class II
MSI Precision Specialty Instruments — Med Saver, 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 II	Pending data

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Manufacturer

Manufacturer: Ambler Surgical, LLC

Sources (1)

FDA UDI 2cbada61-1c3e-4fc7-a2aa-4af07f60300d 35 fields · synced May 30, 2026