AccessGUDID - DEVICE: 27ga Curved Laser Probe (VS0120271)

GUDID

Device Identifier (DI) Information

Brand Name: 27ga Curved Laser Probe
Version or Model: VS0120.27
Commercial Distribution Status: In Commercial Distribution
Catalog Number: VS0120.27
Company Name: Vortex Surgical, Inc.

Primary DI Number: VS0120271
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080375891 *Terms of Use

Device Description: 27ga Curved Laser Probe

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":	Yes
For Single-Use:	Yes
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
HQB	Photocoagulator And Accessories

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
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: 20acd5f8-d0f9-4819-ab7f-a67e05c7b3cd
Public Version Date: November 21, 2022
Public Version Number: 5
DI Record Publish Date: January 29, 2020