FDA.reportPublic FDA data

Gerten Easy Liquid Bubble DMEK

Primary DI
04251047935398
Brand
Gerten Easy Liquid Bubble DMEK
Company
A1 Medical GmbH
Model
HS-0008TS
Device description
Circular peripheral sealing-ring, Ø 10.0mm
Published
2026-06-09
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
HNHRing, Ophthalmic (Flieringa)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNHRing, Ophthalmic (Flieringa)Ophthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04251047935398PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04251047935398042510479353984251047935398

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic surgical probe, reusableA slender, rod-like, hand-held manual surgical instrument intended to be used during an ophthalmic procedure to explore, measure, and/or manipulate ocular tissues (e.g., retraction/manipulation of intraocular structures, lens nucleus splitting, removal of foreign bodies in the eye, LASIK flap lifting); it is neither intended to cut tissue nor hook muscles. It is available with a variety of tip shapes including blunt bulbous, hook and T-shape, and the shaft may be straight or bent; it is made of flexible or rigid metallic and/or synthetic polymer material. 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
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
04251047900174Kratz-Barraquer Wire SpeculumES-00902026-05-29
04251047900655Lieberman Eye SpeculumES-03402026-05-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04251047906688Hofmann-Thornton Fixation RingA1 Medical GmbHHNH2026-06-09
08435194334969AJL Vacuum Centering GuideAJL OPHTHALMIC SAHNH2026-03-12
04058935013547 Ring Fixation Fine Thornton 16Bausch & Lomb GmbHHNH2025-10-26
04058935013554 Ring Fixation Fine-Thornton 13Bausch & Lomb GmbHHNH2025-10-26
00757770418855Bausch + LombBausch & Lomb IncorporatedHNH2025-08-07
00757770481835Bausch + LombBausch & Lomb IncorporatedHNH2025-08-07
00190776406738MillenniumAvalign Technologies, Inc.HNH2025-07-23
G412PH95400MR PHACOCrestpoint Management LimitedHNH2025-06-09
G412PH21150MR PHACOCrestpoint Management LimitedHNH2025-06-07
G412PH21900MR PHACOCrestpoint Management LimitedHNH2025-06-07
G412PH2190080MR PHACOCrestpoint Management LimitedHNH2025-06-07
G412PH2190090MR PHACOCrestpoint Management LimitedHNH2025-06-07
G412PH2190100MR PHACOCrestpoint Management LimitedHNH2025-06-07
G412PH2190110MR PHACOCrestpoint Management LimitedHNH2025-06-07
G412PH2190120MR PHACOCrestpoint Management LimitedHNH2025-06-07
G412PH2190130MR PHACOCrestpoint Management LimitedHNH2025-06-07
G412PH2190140MR PHACOCrestpoint Management LimitedHNH2025-06-07
G412PH2190150MR PHACOCrestpoint Management LimitedHNH2025-06-07
G412PH2190160MR PHACOCrestpoint Management LimitedHNH2025-06-07
G412PH2190170MR PHACOCrestpoint Management LimitedHNH2025-06-07
G412PH2190180MR PHACOCrestpoint Management LimitedHNH2025-06-07
G412PH2190190MR PHACOCrestpoint Management LimitedHNH2025-06-07
G412PH2190200MR PHACOCrestpoint Management LimitedHNH2025-06-07
G412PH2190210MR PHACOCrestpoint Management LimitedHNH2025-06-07
G412PH2190220MR PHACOCrestpoint Management LimitedHNH2025-06-07
G412PH2190230MR PHACOCrestpoint Management LimitedHNH2025-06-07
G412PH2190240MR PHACOCrestpoint Management LimitedHNH2025-06-07
G412PH95000MR PHACOCrestpoint Management LimitedHNH2025-06-07
G412PH9500T0MR PHACOCrestpoint Management LimitedHNH2025-06-07
G412PH95010MR PHACOCrestpoint Management LimitedHNH2025-06-07