AccessGUDID - DEVICE: PASCAL Synthesis TwinStar (577nm/638nm) (00813125015596)

GUDID

Device Identifier (DI) Information

Brand Name: PASCAL Synthesis TwinStar (577nm/638nm)
Version or Model: PASCAL Synthesis 577/638
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SA-06452
Company Name: IRIDEX CORPORATION

Primary DI Number: 00813125015596
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 612920785 *Terms of Use

Device Description: Pascal Synthesis III Twinstar, PA-04, CB-8, 577/638, Packed IRIDEX

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?
62197	Ophthalmic solid-state laser system	An electrically-powered device assembly with a solid-state laser (exited glass/crystal rod), that might be designed to optionally utilize the diode pump laser as a direct therapeutic laser, intended for ophthalmic surgery (e.g., photocoagulation, photodisruption) and/or photostimulation of retinal pigment epithelium (RPE) cells to reverse macular degeneration. It might include a built-in slit lamp, a dosimetry sensor, and/or frequency doubling technology, however it does not include femtosecond pulsing or fundus imaging technology.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GEX	Powered Laser Surgical Instrument
HQF	Laser, Ophthalmic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K170409	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
Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Storage Environment Temperature: between -10 and 55 Degrees Celsius
Storage Environment Humidity: between 0 and 85 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 577nm and 638nm

Device Record Status

Public Device Record Key: 7002f593-858f-4a32-9d3f-f78e972d32ce
Public Version Date: December 13, 2021
Public Version Number: 1
DI Record Publish Date: December 05, 2021