DEVICE: INTEGRA 3 (05060488041761)
Device Identifier (DI) Information
INTEGRA 3
Integra 3 Thermosafe Nikon 2 x SAS
In Commercial Distribution
6-54-100-02
RESEARCH INSTRUMENTS LIMITED
Integra 3 Thermosafe Nikon 2 x SAS
In Commercial Distribution
6-54-100-02
RESEARCH INSTRUMENTS LIMITED
Assisted Reproduction Micromanipulator and Microinjector
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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34169 | Assisted reproduction electromechanical micromanipulator |
An electrically-powered device designed for accurate manipulation of microscopic objects during laboratory in vitro assisted reproduction techniques (ART) [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.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
MQJ | MICROMANIPULATORS AND MICROINJECTORS, ASSISTED REPRODUCTION |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K003142 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
35953c93-62a4-4b84-bee0-7f0026a00879
February 28, 2024
5
December 22, 2017
February 28, 2024
5
December 22, 2017
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
4546790202
origio@origio.com
origio@origio.com