AccessGUDID - DEVICE: PASCAL Synthesis TwinStar (00855005006232)

GUDID

Device Identifier (DI) Information

Brand Name: PASCAL Synthesis TwinStar
Version or Model: PASCAL Synthesis TwinStar (577/638)- PA04
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SA-06452
Company Name: TOPCON MEDICAL LASER SYSTEMS, INC.

Primary DI Number: 00855005006232
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 041376321 *Terms of Use

Device Description: PASCAL Synthesis TwinStar (577/638), PA-04 (PACKED)

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?
16947	Ophthalmic solid-state laser system, photodisruption	A mains electricity (AC-powered) device assembly in which input energy is used to excite a glass/crystal rod to emit a high-power laser beam intended to cause a photodisruptive effect in the eye by forming a plasma and generating mechanical shock waves (microexplosions) that destroy tissue when highly focused (e.g., for cataract extraction, posterior capsulotomy). It typically includes a light source and controls/foot-switch and has a built-in slit lamp biomicroscope, or is coupled to a slit lamp or indirect ophthalmoscope by fixed mirrors. It does not include femtosecond pulsing, frequency doubling, or fundus imaging technology.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
HQF	Laser, ophthalmic
GEX	Powered laser surgical instrument

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: less than 85 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

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

Device Record Status

Public Device Record Key: edeb1a70-46c3-41d9-ae33-aa653f64b16f
Public Version Date: November 18, 2019
Public Version Number: 2
DI Record Publish Date: September 17, 2019