FDA.reportPublic FDA data

EMI Super Micro Needle Holder

Primary DI
04582486863271
Brand
EMI Super Micro Needle Holder
Company
EMI FACTORY CO., LTD.
Model
EMI087
Device description
The product is intended to be used for the purpose of grasping the suture needle during suturing.
Published
2025-07-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
FHQHolder, Needle, Gastroenterologic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FHQHolder, Needle, GastroenterologicGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04582486863271PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04582486863271045824868632714582486863271

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

Contacts#

Phone, Email table
PhoneEmail
0267328556info@emi-factory.co.jp

Regulatory Flags#

DUNS number
714498094
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04582486862687EMI Super Micro Needle HolderEMI0872025-07-11
04582486862694EMI Super Micro Needle HolderEMI0872025-07-11
04582486862700EMI Super Micro Needle HolderEMI0872025-07-11
04582486862717EMI Super Micro Needle HolderEMI0872025-07-11
04582486862724EMI Super Micro Needle HolderEMI0872025-07-11
04582486862731EMI Super Micro Needle HolderEMI0872025-07-11
04582486862748EMI Super Micro Needle HolderEMI0872025-07-11
04582486862755EMI Super Micro Needle HolderEMI0872025-07-11
04582486862762EMI Super Micro Needle HolderEMI0872025-07-11
04582486862779EMI Super Micro Needle HolderEMI0872025-07-11
04582486862786EMI Super Micro Needle HolderEMI0872025-07-11
04582486862793EMI Super Micro Needle HolderEMI0872025-07-11
04582486862809EMI Super Micro Needle HolderEMI0872025-07-11
04582486862816EMI Super Micro Needle HolderEMI0872025-07-11
04582486862823EMI Super Micro Needle HolderEMI0872025-07-11
04582486862830EMI Super Micro Needle HolderEMI0872025-07-11
04582486862847EMI Super Micro Needle HolderEMI0872025-07-11
04582486862854EMI Super Micro Needle HolderEMI0872025-07-11
04582486862861EMI Super Micro Needle HolderEMI0872025-07-11
04582486862878EMI Super Micro Needle HolderEMI0872025-07-11

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Primary DI, Brand, Company table
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