VELYS™ 4516-11-019

GUDID 10748426134813

VELYS™ Drape Robotic-Assist Station Touchscreen

Microtek Medical Inc.

Medical equipment/instrument drape, single-use

• Primary Device ID: 10748426134813
• NIH Device Record Key: 89692dca-2f73-4643-b5ae-39c95081cc23
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VELYS™
• Version Model Number: Equipment Drapes
• Catalog Number: 4516-11-019
• Company DUNS: 106908437
• Company Name: Microtek Medical Inc.
• 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: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00748426134816 [Primary]
GS1	10748426134813 [Package]; Contains: 00748426134816; Package: [15 Units]; In Commercial Distribution
GS1	20748426134810 [Package]; Package: [2 Units]; In Commercial Distribution

FDA Product Code

• PUI: Drape, Surgical, Exempt

Sterilization

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

[10748426134813]

Ethylene Oxide

[10748426134813]

Ethylene Oxide

[10748426134813]

Ethylene Oxide

[10748426134813]

Ethylene Oxide

[10748426134813]

Ethylene Oxide

[10748426134813]

Ethylene Oxide

[10748426134813]

Ethylene Oxide

[10748426134813]

Ethylene Oxide

[10748426134813]

Ethylene Oxide

[10748426134813]

Ethylene Oxide

[10748426134813]

Ethylene Oxide

[10748426134813]

Ethylene Oxide

[10748426134813]

Ethylene Oxide

[10748426134813]

Ethylene Oxide

[10748426134813]

Ethylene Oxide

[10748426134813]

Ethylene Oxide

[10748426134813]

Ethylene Oxide

[10748426134813]

Ethylene Oxide

[10748426134813]

Ethylene Oxide

[10748426134813]

Ethylene Oxide

[10748426134813]

Ethylene Oxide

[10748426134813]

Ethylene Oxide

[10748426134813]

Ethylene Oxide

[10748426134813]

Ethylene Oxide

[10748426134813]

Ethylene Oxide

[10748426134813]

Ethylene Oxide

[10748426134813]

Ethylene Oxide

[10748426134813]

Ethylene Oxide

[10748426134813]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-02-03
• Device Publish Date: 2025-01-24

On-Brand Devices [VELYS™]

• 10748426134820: VELYS™ Drape Navigation Station Touchscreen
• 10748426134813: VELYS™ Drape Robotic-Assist Station Touchscreen
• 10748426134806: VELYS™ Drape Robotic-Assist Station