AccessGUDID - DEVICE: TV-3 Camera Control Unit Aurora II, 3, and Four Series (10841736112134)

GUDID

Device Identifier (DI) Information

Brand Name: TV-3 Camera Control Unit Aurora II, 3, and Four Series
Version or Model: B1-710-59
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: SKYTRON LLC

Primary DI Number: 10841736112134
Issuing Agency: GS1
Commercial Distribution End Date: January 01, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 078375583 *Terms of Use

Device Description: Remote Camera control unit for Precision HD for Aurora II AUR and up.

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?
32265	Surgical video camera	An electro-optical device (e.g., a CCD) designed to obtain moving-picture documentation of an open surgical procedure. The device is designed for transducing visual images as a sequence of electronic data following a pre-established standard; the images are usually displayed sequentially on the screen of a monitor as a video image. The device may include audio recording capabilities.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KQM	Camera, Surgical And Accessories

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: 2ac16f09-5776-4ff4-84c8-1afb7f2eddc1
Public Version Date: February 01, 2019
Public Version Number: 1
DI Record Publish Date: January 01, 2019