FDA.reportPublic FDA data

Inami Ophthalmic Instruments

Primary DI
04547451044314
Brand
Inami Ophthalmic Instruments
Company
INAMI & CO., LTD.
Model
S-9B
Device description
S-9B Forceps Cornea MISHIMA Original Model
Published
2023-10-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
MDMInstrument, Manual, Surgical, General Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MDMInstrument, Manual, Surgical, General UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04547451044314PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04547451044314045474510443144547451044314

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic surgical device handling forceps, reusableA hand-held manual surgical instrument with blades designed to grasp and manipulate a nonimplantable invasive ophthalmic surgical device (e.g., ophthalmic cannula, handless iris retractor) and/or for ophthalmic suturing. It has a tweezers-like design (may be a micro/fine instrument) with two blades joined at the proximal (non-working) end which have variously designed tips at the working end, typically with a slot/groove to accept the ophthalmic device; it is made of metal and is available in various sizes. This is a reusable device intended to be sterilized prior to use.

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
04547451338697INAMILM-110LM-1102026-10-01
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

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Primary DI, Brand, Company table
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