AccessGUDID - DEVICE: v300H Vision System (00867009000413)

GUDID

Device Identifier (DI) Information

Brand Name: v300H Vision System
Version or Model: v300H
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: SYRIS SCIENTIFIC LLC

Primary DI Number: 00867009000413
Issuing Agency: GS1
Commercial Distribution End Date: July 15, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 043184204 *Terms of Use

Device Description: Polarized Illumination System with magnification for enhanced visualization during dermatology and cosmetic procedures.

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):	No
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?
46807	Head-worn lamp	An electrically-powered lamp mounted on a headband, helmet frame, or spectacles and intended to provide light directly onto the field of vision during a dental or surgical procedure. The light typically consists of a magnifying lens, a reflector, a light bulb, and a connection to its integral batteries or battery pack; it is not a fibreoptic light.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KZF	Device, Medical Examination, Ac Powered

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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: b5f153be-091f-4855-9dcb-6ea005ba49e8
Public Version Date: July 17, 2020
Public Version Number: 3
DI Record Publish Date: December 04, 2018