FDA.reportPublic FDA data

EMI Super Micro Needle Holder

Primary DI
04582486860584
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
2025-07-09
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
04582486860584PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04582486860584045824868605844582486860584

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810220800195Adler Instrument CompanyAdler, Inc.FHQ2026-05-26
G453230117BCL0PEAK MEDICALPeak Medical Distribution Inc.FHQ2026-03-23
G453230117BCR0PEAK MEDICALPeak Medical Distribution Inc.FHQ2026-03-23
04059453049339Hermann Medizintechnik GmbHHermann Medizintechnik GmbHFHQ2026-03-10
B382SD9056641000Surgical DirectSurgical Direct, Inc.FHQ2026-03-09
B382SD9056791000Surgical DirectSurgical Direct, Inc.FHQ2026-03-09
00192896106833Matthieu Needle HolderSONTEC INSTRUMENTS, INC.FHQ2026-02-26
B382SD905662170Surgical DirectSurgical Direct, Inc.FHQ2026-02-20
G4254202130My MedicalMy Medical Store LLCFHQ2026-02-17
G4254202200My MedicalMy Medical Store LLCFHQ2026-02-17
G4254202240My MedicalMy Medical Store LLCFHQ2026-02-17
B382SD905434160Surgical DirectSurgical Direct, Inc.FHQ2026-02-05
B382SD90548817LH0Surgical DirectSurgical Direct, Inc.FHQ2026-02-05
B382SD9055891110Surgical DirectSurgical Direct, Inc.FHQ2026-02-05
B382SD9056791160Surgical DirectSurgical Direct, Inc.FHQ2026-02-05
B382SD9084551100Surgical DirectSurgical Direct, Inc.FHQ2026-02-05
00192896122628Glasser Micro Needle HolderSONTEC INSTRUMENTS, INC.FHQ2026-01-22
00192896122673Derf Needle HolderSONTEC INSTRUMENTS, INC.FHQ2026-01-22
00848657076012AED 6250 Mathieu Handle Laparoscopic Needle Holder, 33cm, Curved Left JawNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FHQ2026-01-15
00848657076029AED 6252 Mathieu Handle Laparoscopic Needle Holder, 33cm, Curved Right JawNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FHQ2026-01-15
D928301140LH0"NEEDLE HOLDER MAYO-HEGAR 7"" LEFT HAND TC"W.H. Holden, Inc.FHQ2026-01-05
D9283011450"NEEDLE HOLDER MAYO-HEGAR 8"" / 20CM TC"W.H. Holden, Inc.FHQ2026-01-05
D9283011510"NEEDLE HOLDER OLSEN-HEGAR 4 1/2"" TC"W.H. Holden, Inc.FHQ2026-01-05
D9283011570"NEEDLE HOLDER OLSEN-HEGAR 7 1/4"" TC"W.H. Holden, Inc.FHQ2026-01-05
D9283011600"NEEDLE HOLDER RYDER 5 1/8"" TC"W.H. Holden, Inc.FHQ2026-01-05
D9283011640"NEEDLE HOLDER FRENCH RYDER 9"" TC"W.H. Holden, Inc.FHQ2026-01-05
D9283011650"NEEDLE HOLDER HEANEY 8 1/4"" - 20CM"W.H. Holden, Inc.FHQ2026-01-05
D928301173OS0"NEEDLE HOLDER MINI-RYDER 6"" SM OFF SET HANDLE"W.H. Holden, Inc.FHQ2026-01-05
D92830117470"NEEDLE HOLDER MINI-RYDER 7"" TC NEW PATTERN"W.H. Holden, Inc.FHQ2026-01-05
D928301174D0"NEEDLE HOLDER MINI-RYDER 7"" DELICATE, TC SERRATED"W.H. Holden, Inc.FHQ2026-01-05