Device
Rechargable, illuminated wand with White/Red/Green/Blue LED illumination
Manufacturer
NANO SURGICAL, INC
NANO SURGICAL, INC
Model: 1
Catalog: RGB-1000-PRO
DI: 00850069257163
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: No
First Published: 2026-05-01
Current Version: 2026-05-11
Description
Rechargable, illuminated wand with White/Red/Green/Blue LED illumination
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
66ec79cc-dc6e-4d42-8499-8dec4d9b4a5d
Distribution Status:
In Commercial Distribution
DUNS Number:
118747775
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
Yes
Identifiers
Device ID:
00850069257163
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 12235
Name: Scalpel handle, reusable
Definition:
A device that is an interchangeable component of a scalpel and that functions as a handle designed to mount a compatible blade. This device with the blade become a single-bladed surgical instrument intended to be used by a physician for cutting or dissecting tissue. The device is typically made of metal (e.g., stainless steel or brass). This is a reusable device.
FDA Product Codes
GDZ
Handle, Scalpel
Environmental Conditions
Item #1 - Storage Handling Low - @attributes - Unit:
KiloPascal
Item #1 - Storage Handling Low - @attributes - Value:
80
Item #1 - Storage Handling High - @attributes - Unit:
KiloPascal
Item #1 - Storage Handling High - @attributes - Value:
101
Item #1 - Storage Handling Type:
Storage Environment Atmospheric Pressure
Item #2 - Storage Handling Low - @attributes - Unit:
Percent (%) Relative Humidity
Item #2 - Storage Handling Low - @attributes - Value:
15
Item #2 - Storage Handling High - @attributes - Unit:
Percent (%) Relative Humidity
Item #2 - Storage Handling High - @attributes - Value:
90
Item #2 - Storage Handling Type:
Storage Environment Humidity
Item #3 - Storage Handling Low - @attributes - Unit:
Degrees Celsius
Item #3 - Storage Handling Low - @attributes - Value:
5
Item #3 - Storage Handling High - @attributes - Unit:
Degrees Celsius
Item #3 - Storage Handling High - @attributes - Value:
40
Item #3 - Storage Handling Type:
Storage Environment Temperature