FDA.reportPublic FDA data

Inami Ophthalmic Instruments

Primary DI
04547451334231
Brand
Inami Ophthalmic Instruments
Company
INAMI & CO., LTD.
Model
M-1901A
Device description
A needle holder with scissors tip deveoped by Dr. Goto whole length of 133mm
Published
2023-10-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HXKHolder, Needle; Orthopedic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXKHolder, Needle; OrthopedicOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04547451334231PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04547451334231045474513342314547451334231

GMDN Terms#

Term, Definition table
TermDefinition
Suturing needle holder, reusableA hand-held manual surgical instrument designed to grasp a suture needle when pushing/pulling the needle and attached suture through tissue during suturing. It is typically made of metal and has short serrated jaws at the distal end to provide better grip of the needle. It is available in a wide variety of sizes and designs, such as: 1) a self-retaining, scissors-like design with ring handles at the proximal end; 2) a tweezers-like design with bowed, hinged handles that are operated by squeezing them together; and 3) a heavy-duty pincer-like design. Some types may utilize inserts made of hard materials (e.g., carbide) and include scissor blades. 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
04052536078349neon3Ulrich GmbH & Co. KGHXK2026-06-09
04052536078356neon3Ulrich GmbH & Co. KGHXK2026-06-09
04052536078363neon3Ulrich GmbH & Co. KGHXK2026-06-09
04052536169931neon3Ulrich GmbH & Co. KGHXK2026-06-09
04052536161997neon3Ulrich GmbH & Co. KGHXK2026-06-08
00810158219625PRINCETONPrinceton Medical Group, Inc.HXK2026-04-22
00810158216778PRINCETONPrinceton Medical Group, Inc.HXK2026-04-20
09348811016249INKAThe Trustee for KAISER FAMILY TRUSTHXK2025-11-19
09348811016379INKAThe Trustee for KAISER FAMILY TRUSTHXK2025-11-19
B356DF410180American MedicalsAmerican MedicalsHXK2025-11-10
B7685135310Buxton BioMedicalBuxton Biomedical IncHXK2025-11-03
00810158217454PRINCETONPrinceton Medical Group, Inc.HXK2025-10-08
00810158217461PRINCETONPrinceton Medical Group, Inc.HXK2025-10-08
00840314251268gSourceGSOURCE LLCHXK2025-09-21
04052536078264uCentumUlrich GmbH & Co. KGHXK2025-08-01
04052536078271uCentumUlrich GmbH & Co. KGHXK2025-08-01
04052536078295uCentumUlrich GmbH & Co. KGHXK2025-08-01
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