VIMA

GUDID 00818089020914

VIMA VIDEO MANAGER AND RECORDER ND-00D-T19/P

Nds Surgical Imaging LLC

Video camera surgical microscope system Video camera surgical microscope system Video camera surgical microscope system Video camera surgical microscope system Video camera surgical microscope system Video camera surgical microscope system Video camera surgical microscope system Video camera surgical microscope system Video camera surgical microscope system Video camera surgical microscope system Video camera surgical microscope system

• Primary Device ID: 00818089020914
• NIH Device Record Key: c610ab99-89b1-4d2a-8ef8-150e2f65b9a6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VIMA
• Version Model Number: 90V0003
• Company DUNS: 081712583
• Company Name: Nds Surgical Imaging LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00818089020914 [Primary]

FDA Product Code

• LMD: System, Digital Image Communications, Radiological

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-08-11
• Device Publish Date: 2022-08-03

Devices Manufactured by Nds Surgical Imaging LLC

• 00818089021270 - Endovue: 2024-04-05 PENTAX EMEA, ENDOVUE, 24", EMEA, US, BC-WU24-N1418
• 00818089023021 - ENDOVUE: 2024-03-21 ZIMMER BIOMET, ENDOVUE PLUS 4K 32", BC-WK32-A1B00 (Zimmer Biomet Distributed, Ref # 84-24-3100)
• 00818089020112 - ScaleOR: 2022-10-24 ScaleOR, DVI Input, W/O Fiber, ND-00B-014/0
• 00818089023007 - Radiance: 2022-10-24 12G-SDI CABLES KIT FOR DISPLAYS
• 00818089023014 - Radiance: 2022-10-24 HDMI CABLES KIT FOR DISPLAYS
• 00818089022994 - Radiance: 2022-10-10 MEDTRONIC, RADIANCE ULTRA 32" 4K ZEROWIRE DUO
• 00818089021164 - Radiance: 2022-08-19 OLYMPUS, RADIANCE ULTRA 32", TRUCOLOR, ANALOG SECONDARY, SC-WU32-G1522
• 00818089021171 - Radiance: 2022-08-19 NOVADAQ, RADIANCE ULTRA 32", DIGITAL SECONDARY, SC-WU32-G1520