FDA UDI In Commercial Distribution 🇺🇸 United States

Saberscope™ Video Processing Unit

DI: 00854490007052 · Model: VPUX-1 · XENOCOR, INC.
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Saberscope™ Video Processing Unit
Primary DI
00854490007052
Version / Model
VPUX-1
Catalog Number
VPUX-1
Company Name
XENOCOR, INC.
Labeler DUNS
080306345
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2026-04-20
Public Version
1
Public Version Date
2026-04-28
Public Version Status
New
Public Device Record Key
81a13300-145f-4c47-a63e-a575986a6d8d

Device Description

The Saberscope™ Video Processing Unit (VPU) connects to the Saberscope™ and video display monitor(s). The VPU can connect to up to 4 HDMI outputs. Users can record images and video to a USB drive via the front panel USB port.

Device Characteristics

Single Use
No
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
No
Has Serial Number
Yes
Has Lot/Batch Number
Yes
Has Manufacturing Date
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
GCJ Laparoscope, General & Plastic Surgery
HET Laparoscope, Gynecologic (And Accessories)
GCQ Endoscope, Flexible

GMDN Terms

Code Name
18034 Endoscopic video image processing unit

Identifiers

Type ID
Primary 00854490007052

Customer Contacts

Premarket Submissions

Submission Number Supplement Number
K260177 000