Medpor

FDA UDI

Class II (US FDA UDI)

by Stryker Leibinger

Identity

Trade Name: MEDPOR FDA UDI
Generic Name: Ophthalmic conformer FDA UDI
Device Name: Ocular Conformer - Non vented - Medium FDA UDI
Model / Reference: 9548 FDA UDI
Description: Ocular Conformer - Non vented - Medium FDA UDI

Identifiers

Catalog Number: 9548 FDA UDI
Primary DI / UDI-DI: 07613252086239 FDA UDI
510(k) Number: K972034 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

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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size: Width — 21.0 Millimeter FDA UDI
Length — 24.0 Millimeter FDA UDI

Category: Ophthalmic conformer

Medpor by Stryker Leibinger — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Ophthalmic conformer.

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SILICONE CONFORMER (FLEXIBLE) — FCI S A S FCI 20 22 · Class II
Small Conformer (non-sterile) — Gulden Ophthalmics · Class II
Ambler Surgical — Ambler Surgical, LLC · Class II
Bio-Eye® — INTEGRATED ORBITAL IMPLANTS, INC. · Class II
Silicone Conformer — JARDON EYE PROSTHETICS, INC. · Class II
PROKERA® — BioTissue Holdings Inc. · Class II

Cleared under the same submission

K972034 also covers:

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: Stryker Leibinger

Sources (1)

FDA UDI 39ec1800-8e90-4027-b89d-878ce7139ee4 36 fields · synced Jun 8, 2026