FDA.reportPublic FDA data

N.A.

Primary DI
04049368144915
Brand
N.A.
Company
Geuder Aktiengesellschaft
Model
37604
Catalog number
37604
Device description
N.A.
Published
2021-07-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HNKProbe, trabeculotomy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNKProbe, TrabeculotomyOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04049368144915PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04049368144915040493681449154049368144915

GMDN Terms#

Term, Definition table
TermDefinition
Lacrimal probe, reusableA hand-held, manual, slender rod-like ophthalmic surgical instrument made of flexible metal, with a blunt bulbous tip, used for exploring the lacrimal canal (the lacrimal duct) during an ophthalmic procedure. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
316267202
Device count
1
Premarket exempt
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04049368016328N.A.38240382402021-02-23
04049368145219N.A.38210382102021-02-23
04049368145226N.A.38215382152021-02-23
04049368172505N.A.40006400062021-02-23
04049368172512N.A.40008400082021-02-23
04049368014201N.A.33960339602021-02-23
04049368015420N.A.38634386342021-02-23
04049368114154N.A.31306313062021-02-23
04049368127895N.A.32935329352021-02-23
04049368127925N.A.32936329362021-02-23
04049368127932N.A.32937329372021-02-23
04049368127994N.A.32944329442021-02-23
04049368133810N.A.33831338312021-02-23
04049368140818N.A.36282362822021-02-23
04049368141181N.A.36312363122021-02-23
04049368141631N.A.36364363642021-02-23
04049368141648N.A.36366363662021-02-23
04049368141655N.A.36368363682021-02-23
04049368169680N.A.32947329472021-02-23
04049368171423N.A.38606386062021-02-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04547451338628Inami Ophthalmic InstrumentsINAMI & CO., LTD.HNK2025-06-19
04547451338635Inami Ophthalmic InstrumentsINAMI & CO., LTD.HNK2025-06-19
04547451338642Inami Ophthalmic InstrumentsINAMI & CO., LTD.HNK2025-06-19
04547451336808Inami Ophthalmic InstrumentsINAMI & CO., LTD.HNK2025-06-13
00840306824036Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.HNK2025-01-17
00840306824043Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.HNK2025-01-17
00840306824050Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.HNK2025-01-17
04547451338062Inami Ophthalmic InstrumentsINAMI & CO., LTD.HNK2024-10-07
00840343723910GEN2SURGIX MEDICAL LLCHNK2024-09-19
00887482049280Symmetry HarmsASPEN SURGICAL PRODUCTS, INC.HNK2024-08-20
G586OP7135320Novo SurgicalNOVO SURGICAL, INC.HNK2023-12-18
G586OP7135330Novo SurgicalNOVO SURGICAL, INC.HNK2023-12-18
04547451332381Inami Ophthalmic InstrumentsINAMI & CO., LTD.HNK2023-10-26
04547451332398Inami Ophthalmic InstrumentsINAMI & CO., LTD.HNK2023-10-26
04547451332404Inami Ophthalmic InstrumentsINAMI & CO., LTD.HNK2023-10-26
04547451335337Inami Ophthalmic InstrumentsINAMI & CO., LTD.HNK2023-10-26
04547451335344Inami Ophthalmic InstrumentsINAMI & CO., LTD.HNK2023-10-26
04547451335351Inami Ophthalmic InstrumentsINAMI & CO., LTD.HNK2023-10-26
00190776359508MillenniumAvalign Technologies, Inc.HNK2023-02-22
00841668128022HARMS TRABECULOTOMY PROBE RIGHTKATENA PRODUCTS, INC.HNK2022-12-07
00841668128039HARMS TRABECULOTOMY PROBE LEFTKATENA PRODUCTS, INC.HNK2022-12-07
04049368055662N.A.Geuder AktiengesellschaftHNK2021-07-05
04049368055693N.A.Geuder AktiengesellschaftHNK2021-07-05
04049368055938N.A.Geuder AktiengesellschaftHNK2021-07-05
04049368055952N.A.Geuder AktiengesellschaftHNK2021-07-05
04049368144908N.A.Geuder AktiengesellschaftHNK2021-07-05
00190660127343Ambler SurgicalAMBLER SURGICAL CORP.HNK2021-01-04
00190660127350Ambler SurgicalAMBLER SURGICAL CORP.HNK2021-01-04
00190660127367Ambler SurgicalAMBLER SURGICAL CORP.HNK2021-01-04
0081748902714123ga DEX™ Hassan ForcepsKATALYST SURGICAL LLCHNK2020-11-01