FDA.reportPublic FDA data

IM-11-2VM

Primary DI
04589818020050
Brand
IM-11-2VM
Company
NARISHIGE LIFEMED CO., LTD.
Model
IM-11-2VM Pneumatic Microinjector
Device description
Assisted Reproduction Microinjector
Published
2017-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MQJMicromanipulators And Microinjectors, Assisted Reproduction

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQJMicromanipulators And Microinjectors, Assisted ReproductionObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K113712000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K113712000IM-11 PNEUMATIC MICROINJECTORNarishige Co., Ltd.2012-03-15MQJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04589818020050PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04589818020050045898180200504589818020050

GMDN Terms#

Term, Definition table
TermDefinition
Assisted-reproduction micromanipulator, electricA mains electricity (AC-powered) device designed for accurate manipulation of microscopic objects during laboratory in vitro assisted-reproduction techniques (e.g., intracytoplasmic sperm injection) usually by making small movements under the visual field of a laboratory microscope. It includes precision motors that reproduce the movements of the hand on a microscopic scale (continuous or step-by-step movements performed with an input mechanism such as a joystick) applied to miniature tools which may be included (e.g., fine needles, syringe microinjectors, capillary tubes). The device does not perform its actions following a computerized program.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
631-229-3320info@narishige-usa.com

Regulatory Flags#

DUNS number
693293734
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04589818020562MTK-1VM-Z3MTK-1VM-Z3 Oil Hydraulic Micromanipulator2024-11-08
04589818020302IM-21VMIM-21VM Microinjector2020-04-20
04589818020012IM-9BVMIM-9BVM Microinjector2017-09-23
04589818020029IM-9CVMIM-9CVM Microinjector2017-09-23
04589818020036MM-89VMMM-89VM Motor-Drive Manipulator2017-09-23
04589818020043MN-4VMMN-4VM Coarse Manipulator 2017-09-23
04589818020067MMO-202NDVMMMO-202NDVM Oil Hydraulic Micromanipulator2017-09-23
04589818020074ON3-99D-2VM 120VNAI-5 Manipulator Set2017-09-23
04589818020081NT-88-V3VM 120VNAI-5 Manipulator Set 2017-09-23
04589818020098NT-88-V3VM-N3 120VNAI-5 Manipulator Set 2017-09-23
04589818020104NT-88-V3VM-N4 120VNAI-5 Manipulator Set 2017-09-23
04589818020111IM-HD1VMIM-HD1VM Pneumatic Microinjector2017-10-01
04589818020128IM-HD1TVMIM-HD1TVM Pneumatic Microinjector2017-10-01
04589818020135MTK-1VM-O1MTK-1VM-O1 Oil Hydraulic Micromanipulator2017-10-01
04589818020142MTK-1VM-O2MTK-1VM-O2 Oil Hydraulic Micromanipulator2017-10-01
04589818020159MTK-1VM-O3MTK-1VM-O3 Hydraulic Micromanipulator2017-10-01
04589818020166MTK-1VM-N1MTK-1VM-N1 Oil Hydraulic Micromanipulator2017-10-01
04589818020173MTK-1VM-N2MTK-1VM-N2 Oil Hydraulic Micromanipulator2017-10-01
04589818020180MTK-1VM-N3MTK-1VM-N3 Oil Hydraulic Micromanipulator2017-10-01
04589818020197MTK-1VM-N4MTK-1VM-N4 Oil Hydraulic Micromanipulator2017-10-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06975183900024HARIOMEDHua Yue Medical Technology Co., Ltd.MQJ2025-03-14
06975183900031HARIOMEDHua Yue Medical Technology Co., Ltd.MQJ2025-03-14
06975183900048HARIOMEDHua Yue Medical Technology Co., Ltd.MQJ2025-03-14
06975183900055HARIOMEDHua Yue Medical Technology Co., Ltd.MQJ2025-03-14
10850068289544SFG MicropipettorSPECTRUM FERTILITY GROUP INC.MQJ2024-11-12
04589818020562MTK-1VM-Z3NARISHIGE LIFEMED CO., LTD.MQJ2024-11-08
G4252005200My MedicalMy Medical Store LLCMQJ2023-08-27
04260531792584V-DENUPET HANDLEVITROMED GmbHMQJ2022-12-16
04589818020302IM-21VMNARISHIGE LIFEMED CO., LTD.MQJ2020-04-20
04589818020296NTXVM-N3NARISHIGE LIFEMED CO., LTD.MQJ2018-08-30
04589818020272ON4VMNARISHIGE LIFEMED CO., LTD.MQJ2018-06-01
04589818020289NTXVM-N4NARISHIGE LIFEMED CO., LTD.MQJ2018-06-01
05060488042416INTEGRA 3RESEARCH INSTRUMENTS LIMITEDMQJ2018-02-23
05060488042423INTEGRA 3RESEARCH INSTRUMENTS LIMITEDMQJ2018-02-23
05060488042430INTEGRA 3RESEARCH INSTRUMENTS LIMITEDMQJ2018-02-23
05060488042447INTEGRA 3RESEARCH INSTRUMENTS LIMITEDMQJ2018-02-23
05060488042782INTEGRA 3RESEARCH INSTRUMENTS LIMITEDMQJ2018-02-23
05060488043451INTEGRA 3RESEARCH INSTRUMENTS LIMITEDMQJ2018-02-23
05060488043611INTEGRA 3RESEARCH INSTRUMENTS LIMITEDMQJ2018-02-23
05060488044755INTEGRA 3RESEARCH INSTRUMENTS LIMITEDMQJ2018-02-23
05060488044762INTEGRA 3RESEARCH INSTRUMENTS LIMITEDMQJ2018-02-23
05060488044779INTEGRA 3RESEARCH INSTRUMENTS LIMITEDMQJ2018-02-23
05060488044786INTEGRA 3RESEARCH INSTRUMENTS LIMITEDMQJ2018-02-23
05060488044984INTEGRA 3RESEARCH INSTRUMENTS LIMITEDMQJ2018-02-23
05060488041754INTEGRA 3RESEARCH INSTRUMENTS LIMITEDMQJ2017-12-22
05060488041761INTEGRA 3RESEARCH INSTRUMENTS LIMITEDMQJ2017-12-22
05060488041778INTEGRA 3RESEARCH INSTRUMENTS LIMITEDMQJ2017-12-22
05060488041785INTEGRA 3RESEARCH INSTRUMENTS LIMITEDMQJ2017-12-22
05060488041792INTEGRA 3RESEARCH INSTRUMENTS LIMITEDMQJ2017-12-22
05060488041808INTEGRA 3RESEARCH INSTRUMENTS LIMITEDMQJ2017-12-22