AccessGUDID - DEVICE: PhotonGuide (00816728020646)

GUDID

Device Identifier (DI) Information

Brand Name: PhotonGuide
Version or Model: Wide / Flat
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 104015
Company Name: STRYKER CORPORATION

Primary DI Number: 00816728020646
Issuing Agency: GS1
Commercial Distribution End Date: June 27, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 196548481 *Terms of Use

Device Description: Illuminator, Wide/Flat

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?
32241	Fibreoptic operating light system	A system of lights intended to be used in the operating room (OR) to illuminate the surgical site over a prolonged period for optimal visualization of small, low-contrast objects at varying depths or through small incisions. It operates through light provided by a light source, usually located outside of the surgical field, which is delivered through fibreoptic cables to the site of operation. The cables will be mounted, e.g., from the ceiling or attached to a suitable floor mount, or they may possibly connect directly to the surgeons head-worn head light.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FSZ	Light, Surgical, Carrier

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
No Device Sizes

Device Record Status

Public Device Record Key: 2d2201d3-f8fd-4e2b-abc6-0cbdefb243bf
Public Version Date: September 26, 2022
Public Version Number: 7
DI Record Publish Date: June 03, 2019