FDA.reportPublic FDA data

Inami Ophthalmic Instruments

Primary DI
04547451332404
Brand
Inami Ophthalmic Instruments
Company
INAMI & CO., LTD.
Model
M-2215S
Device description
M-2215S TMH ORIGINAL edition, Straight
Published
2023-10-26
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
04547451332404PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04547451332404045474513324044547451332404

GMDN Terms#

Term, Definition table
TermDefinition
Trabeculotome, reusableA hand-held manual ophthalmic surgical instrument intended to be used to perform a trabeculotomy [surgical opening of the sinus venosus sclerae (Schlemm’s canal)] to reduce intraocular pressure (IOP) for the prevention/treatment of glaucoma. It is typically made of high-grade stainless steel, having a two-pronged fork at the distal end and a handle at the proximal end. It enables guided unroofing of Schlemm's canal (an endothelium-lined tube) through insertion of one of the prongs via incisions and flaps made in the eye. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
690688742
Device count
1
Premarket exempt
true
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04547451339212INAMI25R-0000822026-01-29
04547451338338INAMIKDM-42025-12-19
04547451328650INAMIKDM-32023-07-27
04547451339045Inami25R-0000692025-12-05
04547451338062Inami Ophthalmic InstrumentsM-2225S2024-10-07
00454745102558INAMIL-05442025-11-12
04547451081777INAMIL-05412025-11-12
04547451338321INAMIL-03002025-08-29
04547451043744Inami Ophthalmic InstrumentsS-3252025-08-06
04547451338628Inami Ophthalmic InstrumentsM-2221S2025-06-19
04547451338635Inami Ophthalmic InstrumentsM-2221L2025-06-19
04547451338642Inami Ophthalmic InstrumentsM-2221R2025-06-19
04547451336808Inami Ophthalmic InstrumentsM-22252025-06-13
04547451333883Inami Ophthalmic InstrumentsK-0391T2025-05-28
04547451336815Inami Ophthalmic InstrumentsDS-0162025-04-09
04547451337560Inami Ophthalmic InstrumentsDS-0162025-04-09
04547451026273INAMIL-2510B2025-03-06
04547451026280INAMIL-2510HB2025-03-06
04547451336792Inami Ophthalmic InstrumentsS-892024-10-08
04547451337904Inami Ophthalmic InstrumentsS-942024-10-08

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
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
04049368144915N.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