ScaleOR

GUDID 00818089020112

ScaleOR, DVI Input, W/O Fiber, ND-00B-014/0

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

• Primary Device ID: 00818089020112
• NIH Device Record Key: 09d0e368-20de-426a-8482-b70d213a5d07
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ScaleOR
• Version Model Number: 90T0009
• 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	00818089020112 [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: 2022-10-24
• Device Publish Date: 2022-10-15

On-Brand Devices [ScaleOR ]

• 00818089020891: ScaleOR, VGA Input, HDBaseT, ND-00B-021/0
• 00818089021720: ScaleOR, VGA Input, W/ Single Fiber, ND-00B-015/0
• 00818089021713: ScaleOR, SDI Input, W/ Single Fiber, ND-00B-015/0
• 00818089021706: ScaleOR, DVI Input, W/ Single Fiber, ND-00B-015/0
• 00818089020136: ScaleOR, VGA Input, W/O Fiber, ND-00B-014/0
• 00818089020129: ScaleOR, SDI Input, W/O Fiber, ND-00B-014/0
• 00818089021782: Custom Karl Storz, ScaleOR, DVI Input, W/O Fiber, No Accessory, ND-00B-014/0
• 00818089021775: ScaleOR, DVI Input, W/O Fiber, W/ DVI and 3G-SDI Cables, ND-00B-014/0
• 00818089021768: Custom Brainlab, ConductOR, ND-00B-M11/1
• 00818089021751: Custom Karl Storz, ScaleOR, DVI Input, W/O Fiber, ND-00B-014/0
• 00818089021744: ConductOR China, ND-00B-M11/1
• 00818089021737: ScaleOR, S-Video/Comp Input, W/ Single Fiber, ND-00B-015/0
• 00818089020884: ScaleOR, SDI Input, HDBaseT, ND-00B-021/0
• 00818089020877: ScaleOR, DVI Input, HDBaseT, ND-00B-021/0
• 00818089020143: ScaleOR, S-Video/Comp Input, W/O Fiber, ND-00B-014/0
• 00818089020907: ScaleOR, S-Video/Comp Input, HDBaseT, ND-00B-021/0
• 00818089020112: ScaleOR, DVI Input, W/O Fiber, ND-00B-014/0