XenoBox XD-A1

GUDID 00854490007021

aka Xenoscope Dongle. Video Processing Unit (VPU)

XENOCOR, INC.

Endoscopic video image processing unit

• Primary Device ID: 00854490007021
• NIH Device Record Key: 2d95b112-13d1-4da9-b1a6-e18c0d670c96
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: XenoBox
• Version Model Number: XD-A1
• Catalog Number: XD-A1
• Company DUNS: 080306345
• Company Name: XENOCOR, 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00854490007021 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161838

FDA Product Code

• HET: Laparoscope, Gynecologic (And Accessories)

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: 2024-12-25
• Device Publish Date: 2024-12-17

Devices Manufactured by XENOCOR, INC.

• 00854490007007 - Xenoscope 0°: 2024-12-25 Xenoscope, 0°, 10mm x 36 cm
• 00854490007014 - Xenoscope 30°: 2024-12-25 Xenoscope, 30°, 10mm x 36 cm
• 00854490007021 - XenoBox: 2024-12-25aka Xenoscope Dongle. Video Processing Unit (VPU)
• 00854490007021 - XenoBox: 2024-12-25 aka Xenoscope Dongle. Video Processing Unit (VPU)
• 00854490007038 - Saberscope: 2024-12-25 5 mm Articulating Laparoscope