XQSLC1

GUDID 00724995153083

The IDSS-SLC Version 7 OR Integration software module allows the remote control of surgical lights during a surgical procedure.

BLACK DIAMOND VIDEO, INC.

Operating room audiovisual data/device management system application software

• Primary Device ID: 00724995153083
• NIH Device Record Key: 812b3c7c-8bff-4bf6-b572-97b8cc739520
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: IDSS-SLC
• Catalog Number: XQSLC1
• Company DUNS: 556373053
• Company Name: BLACK DIAMOND VIDEO, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	00724995153083 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133413

FDA Product Code

• FTA: Light, surgical, accessories

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-02-26
• Device Publish Date: 2017-06-06

Devices Manufactured by BLACK DIAMOND VIDEO, INC.

• 00724995220587 - HexaVue: 2024-02-16 HexaVue IP Surgical Light Control Feature
• 00724995220594 - HexaVue: 2024-02-16 HexaVue IP In-Light Camera Control Feature
• 00724995218799 - Vividimage W 4K: 2022-08-29 The Vividimage W 65-inch 4K Medical Grade Display is designed to meet surgery room viewing needs of healthcare professionals th
• 00724995195113 - Vividimage 4K: 2021-05-03 The Vividimage 31-inch 4K Surgical Display is designed for the most demanding surgical environments through its delivery of real
• 00724995195137 - Vividimage 4K: 2021-05-03 The Vividimage 31-inch 4K Surgical Display is designed for the most demanding surgical environments through its delivery of real
• 00724995198459 - FREE5: 2021-05-03 The HD FREE5 Camera System allows surgeons to view and record the surgical site from virtually any orientation or angle.
• 00724995198473 - NA: 2021-05-03 The IDSS Integration System with Surgical Camera Control is an integrated audio-visual system which combines monitors, medical
• 00724995199135 - Harmony iQ: 2021-05-03 The Surgical Light Control and Surgical Camera Control for the Harmony IQ 2800 Integration Systems promotes efficient and prompt