Model: RX1
Catalog: VI360/5
DI: B366U1VI3605
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: No
First Published: 2026-05-19
Current Version: 2026-05-27
Description
USB VIDEO CAMERA
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
750a7209-af88-4107-a865-8449127ed17c
Distribution Status:
In Commercial Distribution
DUNS Number:
043555079
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
B366U1VI3605
Type:
Primary
Issuing Agency:
HIBCC
GMDN
Code: 32265
Name: Surgical video camera
Definition:
An electro-optical device (e.g., a CCD) designed to obtain moving-picture documentation of an open surgical procedure. The device is designed for transducing visual images as a sequence of electronic data following a pre-established standard; the images are usually displayed sequentially on the screen of a monitor as a video image. The device may include audio recording capabilities.
FDA Product Codes
FWD
Camera, Television, Microsurgical, Without Audio
Environmental Conditions
Item #1 - Storage Handling Low - @attributes - Unit:
Degrees Celsius
Item #1 - Storage Handling Low - @attributes - Value:
10
Item #1 - Storage Handling High - @attributes - Unit:
Degrees Celsius
Item #1 - Storage Handling High - @attributes - Value:
40
Item #1 - Storage Handling Type:
Handling Environment Temperature
Item #2 - Storage Handling Low - @attributes - Unit:
Percent (%) Relative Humidity
Item #2 - Storage Handling Low - @attributes - Value:
35
Item #2 - Storage Handling High - @attributes - Unit:
Percent (%) Relative Humidity
Item #2 - Storage Handling High - @attributes - Value:
75
Item #2 - Storage Handling Type:
Handling Environment Humidity
Item #3 - Storage Handling Low - @attributes - Unit:
KiloPascal
Item #3 - Storage Handling Low - @attributes - Value:
70
Item #3 - Storage Handling High - @attributes - Unit:
KiloPascal
Item #3 - Storage Handling High - @attributes - Value:
106
Item #3 - Storage Handling Type:
Handling Environment Atmospheric Pressure
Item #4 - Storage Handling Low - @attributes - Unit:
Degrees Celsius
Item #4 - Storage Handling Low - @attributes - Value:
-30
Item #4 - Storage Handling High - @attributes - Unit:
Degrees Celsius
Item #4 - Storage Handling High - @attributes - Value:
50
Item #4 - Storage Handling Type:
Storage Environment Temperature
Item #5 - Storage Handling Low - @attributes - Unit:
Percent (%) Relative Humidity
Item #5 - Storage Handling Low - @attributes - Value:
10
Item #5 - Storage Handling High - @attributes - Unit:
Percent (%) Relative Humidity
Item #5 - Storage Handling High - @attributes - Value:
95
Item #5 - Storage Handling Type:
Storage Environment Humidity
Item #6 - Storage Handling Low - @attributes - Unit:
KiloPascal
Item #6 - Storage Handling Low - @attributes - Value:
50
Item #6 - Storage Handling High - @attributes - Unit:
KiloPascal
Item #6 - Storage Handling High - @attributes - Value:
106
Item #6 - Storage Handling Type:
Storage Environment Atmospheric Pressure