FDA.reportPublic FDA data

INTEGRA 3

Primary DI
05060488041815
Brand
INTEGRA 3
Company
RESEARCH INSTRUMENTS LIMITED
Model
Integra 3 Thermosafe Olympus 1 x SAS & 1 x SAS-SE
Catalog number
6-54-100-07
Device description
Assisted Reproduction Micromanipulator and Microinjector
Published
2017-12-22
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
K003142000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K003142000MICROMANIPULATORResearch Instruments , Ltd.2000-11-22MQJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060488041815PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060488041815050604880418155060488041815

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
4546790202origio@origio.com

Regulatory Flags#

DUNS number
536139413
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060554120956K-SystemsG210 InviCellK595002025-02-25
05060554120963K-SystemsG210 InviCellK595002025-02-25
00888937014488TITANTITAN WTIVFE IVF 120V SERIAL NUMBERWTIVFE-W51202024-09-20
00888937014587MARSMARS 1800 IVF WS 6FT W/RIGHT ELEC HEATWM1800RE2024-09-20
00888937014600MARSMARS 1800 IVF WS 6FT W/LEFT ELEC HEATWM1800LE2024-09-20
00888937014648MARSMARS 1800 MULTI ELEC WS 6FT ANTIVIBRATIONWM1800MPE2024-09-20
00888937014655TITANTITAN IVF FIXED STAND 75-80CMWTIVFE2024-09-20
00888937014662TITANTITAN WTIVFEADJ IVF 120V SERIAL NUMBERWTIVFEADJ-W51202024-09-20
00888937014679TITANTITAN IVF ADJUSTABLE HEIGHTWTIVFEADJ2024-09-20
00888937020243MARSMARS 900E IVF 240V SERIAL NUMBERWM900E-W52402024-09-20
00888937020281MARSMARS 1800LE IVF 240V SERIAL NUMBERWM1800DE-W52402024-09-20
00888937020298MARSMARS 1800LE IVF 240V SERIAL NUMBERWM1800LE-W52402024-09-20
00888937020304MARSMARS 1800LE IVF 240V SERIAL NUMBERWM1800MPE-W52402024-09-20
00888937020311MARSMARS 1800RE IVF 240V SERIAL NUMBERWM1800RE-W52402024-09-20
00888937020328TITANTITAN WTIVFE IVF 240V SERIAL NUMBERWTIVFE-W52402024-09-20
00888937020335TITANTITAN WTIVFEADJ IVF 240V SERIAL NUMBERWTIVFEADJ-W52402024-09-20
00888937024685MARSMARS 900 LAF 3FT MARS WORKSTATIONWM9002024-09-20
00888937024722TITANTITAN LAF BENCHTOP MODELWTLAF2024-09-20
05060554120024CODAK59549 Coda Inline Filter for G185 USK595492024-09-20
05060554120086G185K22400-110 G185 Standard 110V Incubator ROWK22400-1102024-09-20

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