FDA.reportPublic FDA data

Gerten Easy Liquid Bubble DMEK Cannula

Primary DI
04251047934520
Brand
Gerten Easy Liquid Bubble DMEK Cannula
Company
A1 Medical GmbH
Model
L-1309
Device description
27G, 0.3mm Port above, straight, self-sealing
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
HMXCannula, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HMXCannula, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04251047934520PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04251047934520042510479345204251047934520

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusableA rigid or semi-rigid tube (non-illuminating) designed to be inserted into the eye to facilitate infusion, irrigation, and/or aspiration of fluids/gases during ophthalmic surgery (e.g., phacoemulsification, vitreoretinal surgery, sub-Tenon’s anaesthesia, capsule polishing). It is a single- or multi-lumen device, typically made of high-grade stainless steel, and may include a length of flexible tubing. It may be blunt, or include a sharp angled tip/hook (e.g., irrigating cystotome for capsulotomy), however it does not have a sharp bevelled end for initial puncture of the eye (i.e., not a needle). This is a reusable device intended to be sterilized prior to use.

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
04251047903076Kuglen Iris Hook and Lens ManipulatorHS-0000TS2026-06-09
04251047903090Rosen Phaco SplitterHS-0010TS2026-06-09
04251047903151Nagahara Phaco-ChopperHS-0040TS2026-06-09
04251047903175Nagahara Phaco-ChopperHS-0050TS2026-06-09
04251047903274Lester IOL-ManipulatorHS-0110TS2026-06-09
04251047903359Sinskey II Lens Manipulating HookHS-0150TS2026-06-09
04251047903571Rowen Phaco Spatula & Bechert Nucleus RotatorHS-0260TS2026-06-09
04251047903632Chang Phaco ChopperHS-0310TS2026-06-09
04251047903755Nagahara Phaco-ChopperHS-03602026-06-09
04251047904745Sinskey II Lens Manipulating HookHS-06902026-06-09
04251047905346Kuglen Iris Hook and Lens ManipulatorHS-09402026-06-09
04251047906688Hofmann-Thornton Fixation RingHS-16102026-06-09
04251047913549Bechert Nucleus RotatorHS-0630C2026-06-09
04251047924804Sterilizing CaseMIS-02102026-06-09
04251047926389Sterilization Tray with LidMIS-06112026-06-09
04251047928604Drysdale Nucleus ManipulatorHS-0091TS2026-06-09
04251047930386Double-level Sterilization TrayMIS-06152026-06-09
04251047934155Gerten Dilator for the Easy Liquid Bubble DMEKHS-0007TS2026-06-09
04251047935398Gerten Easy Liquid Bubble DMEKHS-0008TS2026-06-09
04251047900174Kratz-Barraquer Wire SpeculumES-00902026-05-29

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776403843MillenniumAvalign Technologies, Inc.HMX2026-07-21
00190776400569MillenniumAvalign Technologies, Inc.HMX2026-07-19
00860015282040Intrace USAPILOTIS TECH LLCHMX2026-07-03
00840285320796Walcott Rx ProductsWalcott Rx Product IncHMX2026-06-26
00840319759189Hayden MedicalHayden Medical, Inc.HMX2026-06-24
04251047903151Nagahara Phaco-ChopperA1 Medical GmbHHMX2026-06-09
04251047903175Nagahara Phaco-ChopperA1 Medical GmbHHMX2026-06-09
04251047903632Chang Phaco ChopperA1 Medical GmbHHMX2026-06-09
04251047903755Nagahara Phaco-ChopperA1 Medical GmbHHMX2026-06-09
04251047915086Akahoshi Combo Pre-ChopperA1 Medical GmbHHMX2026-05-29
04251047923296Rycroft Air Injection CannulaA1 Medical GmbHHMX2026-05-29
04251047923388Sauter Hydrodissection CannulaA1 Medical GmbHHMX2026-05-29
04251047933295Gerten Clear Cornea DALK CannulaA1 Medical GmbHHMX2026-05-29
08600088329110Maskin MG Probe 1mmMGD INNOVATIONS, LLCHMX2026-05-07
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07612717072091FINESSE ModifEYEAlcon Laboratories, Inc.HMX2024-09-26
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07612717072060FINESSE ModifEYEAlcon Laboratories, Inc.HMX2024-09-25
07612717072077FINESSE ModifEYEAlcon Laboratories, Inc.HMX2024-09-25
08052276019639Silicone Oil Infusion Line 23G for TocarAKTIVE SRLHMX2024-01-11
08052276019646Silicone Oil Infusion Line 25G for TrocarAKTIVE SRLHMX2024-01-11
08052276019653Infusion Line Silicone 20G 4mm for Trocar universalAKTIVE SRLHMX2024-01-11