DEVICE: INTEGRA 3 (05060488041808)

Device Identifier (DI) Information

INTEGRA 3
Integra 3 Thermosafe Olympus 2 x SAS
In Commercial Distribution
6-54-100-06
RESEARCH INSTRUMENTS LIMITED
05060488041808
GS1

1
536139413 *Terms of Use
Assisted Reproduction Micromanipulator and Microinjector
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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. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
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.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
MQJ MICROMANIPULATORS AND MICROINJECTORS, ASSISTED REPRODUCTION
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K003142 000
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

ed5203e8-75e0-4588-b333-7926f9dd7f62
February 28, 2024
5
December 22, 2017
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
No
Yes
No
Yes
No CLOSE

Customer Contact

[?]
4546790202
origio@origio.com
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