AccessGUDID - DEVICE: PhotonGuide XT System (00816728020103)

GUDID

Device Identifier (DI) Information

Brand Name: PhotonGuide XT System
Version or Model: Narrow / Flat
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 104008XT
Company Name: INVUITY, INC.

Primary DI Number: 00816728020103
Issuing Agency: GS1
Commercial Distribution End Date: January 02, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 175697908 *Terms of Use

Device Description: The PhotonGuide XT System is intended to provide surgical site illumination from a high intensity light source.

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?
48036	Surgical instrument fibreoptic light	A sterile device with a fibreoptic bundle core designed to be affixed to the surface of a surgical instrument, typically a retractor, to conduct cold light from a connected fibreoptic light cable and light source into a surgical wound for illumination during a surgical intervention. It typcially emits cold light only through its tip to eliminate glare, and may have a self-adhesive coating for attachment to the surgical instrument. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
FDG	Retractor, Fiberoptic

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: 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
Device Size Text, specify: Angle: Flat
Device Size Text, specify: Width: Narrow

Device Record Status

Public Device Record Key: 680205bb-9d13-42be-b51f-7c5ec900e889
Public Version Date: April 24, 2020
Public Version Number: 4
DI Record Publish Date: September 22, 2016