FDA.reportPublic FDA data

Gerten Cornea Zone Marker

Primary DI
04251047934674
Brand
Gerten Cornea Zone Marker
Company
A1 Medical GmbH
Model
HS-1831
Device description
8.0mm, with Marking of the Cornea-Center
Published
2026-05-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
HMRMarker, Ocular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HMRMarker, OcularOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04251047934674PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04251047934674042510479346744251047934674

GMDN Terms#

Term, Definition table
TermDefinition
Corneal marker, reusableA manual instrument intended to be used to imprint, indent, and/or incise corneal tissue prior to an ophthalmic surgical procedure. It is typically made of high-grade stainless steel and includes a long slender handle with a distal end having characteristics for producing specific markings. The device may have a defined pattern of fine marking surfaces (e.g., cross hairs, symmetrical or asymmetrical interlinking wires) that simultaneously engage corneal tissue. Some types are used with a corneal marking pad to transfer ink to the anterior of the eye; other types are used with a slit lamp to precisely incise vertical and horizontal points for precision alignment. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
9999999999info@a1-medical.com

Regulatory Flags#

DUNS number
342514232
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04251047900174Kratz-Barraquer Wire SpeculumES-00902026-05-29
04251047900655Lieberman Eye SpeculumES-03402026-05-29
04251047900679Lieberman Eye SpeculumES-03502026-05-29
04251047900686Lieberman Eye SpeculumES-0350C2026-05-29
04251047902956Kelly Descemet Membrane PunchC-07302026-05-29
04251047915086Akahoshi Combo Pre-ChopperF-34202026-05-29
04251047920554Vannas Capsulotomy ScissorsS-04402026-05-29
04251047921278Metzenbaum ScissorsS-07802026-05-29
04251047923296Rycroft Air Injection CannulaL-07102026-05-29
04251047923388Sauter Hydrodissection CannulaL-08102026-05-29
04251047923630Kratz Capsule PolisherL-10502026-05-29
04251047924378Castroviejo CaliperM-00102026-05-29
04251047925849Vera Fixation HookES-07252026-05-29
04251047926204Irrigation HandpieceL-13112026-05-29
04251047930003Aspiration HandpieceL-13312026-05-29
04251047931680Super-Cut Westcott Tenotomy ScissorsS-0220SC2026-05-29
04251047931697Super-Cut Westcott Tenotomy ScissorsS-0250SC2026-05-29
04251047932021Super-Cut Stevens Tenotomy ScissorsS-0680SC2026-05-29
04251047932373Mod. Krumeich Eye SpeculumES-02872026-05-29
04251047933295Gerten Clear Cornea DALK CannulaL-13082026-05-29

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00190776420482MillenniumAvalign Technologies, Inc.HMR2026-04-16
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00190776418984MillenniumAvalign Technologies, Inc.HMR2026-04-13
00841668144299KatenaKATENA PRODUCTS, INC.HMR2026-03-31
00841668144305KatenaKATENA PRODUCTS, INC.HMR2026-03-31
00841668144312KatenaKATENA PRODUCTS, INC.HMR2026-03-31
00841668144329KatenaKATENA PRODUCTS, INC.HMR2026-03-31
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00841668144350KatenaKATENA PRODUCTS, INC.HMR2026-03-31
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G346BP01RSS0Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHMR2026-03-02
G346ET160Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHMR2026-02-17
00642356004709Mastel Surgical Inc.Mastel Surgical Inc.HMR2026-02-11
B382S34556140Surgical DirectSurgical Direct, Inc.HMR2026-02-04
B382S4901000Surgical DirectSurgical Direct, Inc.HMR2026-02-04
B382S5616020Surgical DirectSurgical Direct, Inc.HMR2026-02-04
G346ET390Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHMR2026-01-21
B382S345201000Surgical DirectSurgical Direct, Inc.HMR2025-12-10
G22312270490Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHMR2025-11-05
B382SD9345561010Surgical DirectSurgical Direct, Inc.HMR2025-09-18
B382SD934557100Surgical DirectSurgical Direct, Inc.HMR2025-09-18
00757770492312Bausch + LombBausch & Lomb IncorporatedHMR2025-08-04
00194613001964MSI Precision Specialty InstrumentsMed Saver, Inc.HMR2025-08-01