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
05060488041730
GS1

1
536139413 *Terms of Use
Assisted Reproduction Laser
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
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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FDA Product Code

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Product Code Product Code Name
MRX System, assisted reproduction laser
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K141434 000
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Sterilization

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

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

35a375bb-330f-4925-90b9-e56f8bc5c1b5
July 06, 2018
3
December 22, 2017
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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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)

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No
No
None
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Production Identifier(s) in UDI

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No
Yes
No
Yes
No CLOSE

Customer Contact

[?]
4546790202
origio@origio.com
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