ScaleOR

GUDID 00818089021751

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

Nds Surgical Imaging LLC

Video camera surgical microscope system

• Primary Device ID: 00818089021751
• NIH Device Record Key: 72417266-53f2-48f0-bdbf-e0369e39a1e3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ScaleOR
• Version Model Number: 90T0018
• 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	00818089021751 [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: 2022-08-03
• Device Publish Date: 2022-07-26

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