AccessGUDID - DEVICE: NA (00724995163723)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: IDSS-SLC Version 8
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: XQSLC1
Company Name: BLACK DIAMOND VIDEO, INC.

Primary DI Number: 00724995163723
Issuing Agency: GS1
Commercial Distribution End Date: June 06, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 556373053 *Terms of Use

Device Description: The IDSS-SLC Version 8 OR Integration software module allows the remote control of surgical lights during a surgical procedure and the software provides support for routing higher resolution 4K video when used with supporting 4K routing hardware installed in the BDV IDSS integration system.

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?
59047	Operating room audiovisual data/device management system application software	An application software program, routines, and/or algorithms intended to be used in an operating room audiovisual data/device management system to enable the system to function according to its intended purpose. The software typically supports remote control of medical and non-medical devices, data management/documentation, and data communication/transfer within and outside of the operating room (OR) [e.g., teleconferencing, teaching/ telesurgery, networking with hospital systems]; it is not intended for long-term storage of patient demographics. It is typically installed into a dedicated integrated network of computers and peripherals.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FTA	Light, surgical, 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: fe92d139-05a5-4e40-a77d-7b6075397af6
Public Version Date: June 07, 2024
Public Version Number: 2
DI Record Publish Date: February 28, 2019