NA

Basic Information

• Brand Name: NA
• Primary DI: 00724995163723
• Version / Model: IDSS-SLC Version 8
• Catalog Number: XQSLC1
• Company Name: BLACK DIAMOND VIDEO, INC.
• Labeler DUNS: 556373053
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-02-28
• Public Version: 1
• Public Version Date: 2019-03-11
• Public Version Status: New
• Public Device Record Key: fe92d139-05a5-4e40-a77d-7b6075397af6

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

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FTA	Light, surgical, accessories	General, Plastic Surgery	878.4580	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00724995163723	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]