Saberscope XSA-0-0536

GUDID 00854490007038

5 mm Articulating Laparoscope

XENOCOR, INC.

Flexible video laparoscope

• Primary Device ID: 00854490007038
• NIH Device Record Key: 9c920c72-5389-4d61-81f3-2e61b0137699
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Saberscope
• Version Model Number: XSA-0-0536
• Catalog Number: XSA-0-0536
• 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: 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00854490007038 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193315

FDA Product Code

• GCJ: Laparoscope, General & Plastic Surgery

Sterilization

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

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: 2024-12-25 aka Xenoscope Dongle. Video Processing Unit (VPU)
• 00854490007038 - Saberscope: 2024-12-255 mm Articulating Laparoscope
• 00854490007038 - Saberscope: 2024-12-25 5 mm Articulating Laparoscope