DEVICE: Saturn 5 Laser System (05060488041730)
Device Identifier (DI) Information
Saturn 5 Laser System
Saturn 5 Active - Nikon Ti with Nikon XY Stage 20x
In Commercial Distribution
6-47-500-05
RESEARCH INSTRUMENTS LIMITED
Saturn 5 Active - Nikon Ti with Nikon XY Stage 20x
In Commercial Distribution
6-47-500-05
RESEARCH INSTRUMENTS LIMITED
Assisted Reproduction Laser
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? |
---|---|---|---|---|
61181 | Assisted reproduction laser system |
A portable, mains electricity (AC-powered) device assembly in which input energy is used to excite a diode to emit a low-intensity laser beam to ablate the zona pellucida of an embryo during in vitro fertilization (IVF), typically as part of laser-assisted embryo hatching or embryo biopsy. It is intended to be used in conjunction with a compatible inverted-stage light microscope and typically includes a combined laser/microscope objective, a control unit, a camera, and additional supportive devices (e.g., software, foot-switch).
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
MRX | System, assisted reproduction laser |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K141434 | 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
35a375bb-330f-4925-90b9-e56f8bc5c1b5
February 28, 2024
4
December 22, 2017
February 28, 2024
4
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