AccessGUDID - DEVICE: Saturn 5 Laser System (05060488043635)

GUDID

Device Identifier (DI) Information

Brand Name: Saturn 5 Laser System
Version or Model: Saturn 5 Active Olympus IX50-70
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 6-47-500-24
Company Name: RESEARCH INSTRUMENTS LIMITED

Primary DI Number: 05060488043635
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 536139413 *Terms of Use

Device Description: Assisted Reproduction Laser

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

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).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MRX	System, assisted reproduction laser

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0165274a-a100-40d3-a2e0-b0a859cf4aa7
Public Version Date: February 28, 2024
Public Version Number: 4
DI Record Publish Date: February 23, 2018