Model: 1
Catalog: RGB-1015-10
DI: 00850069257132
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: No
OTC: No
First Published: 2026-04-29
Current Version: 2026-05-07
Description
Blade cartridge loader, 5-count #10 blades
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
999be06b-625a-47fe-b7c1-f37cbacb3103
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
Item #1 - Pkg Type:
Case
Item #1 - Device ID:
10850069257139
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
10
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
00850069257132
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
00850069257132
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
GMDN
Code: 37445
Name: Manual scalpel blade, single-use
Definition:
An interchangeable device designed to mount a compatible handle and function as the cutting edge of a scalpel. It is made of high-grade stainless steel alloy and is used as a surgical instrument to cut and dissect tissues. Safety mechanisms (e.g., a retractable protective guard made of plastic) may be included. This is a single-use device.
FDA Product Codes
GES
Blade, Scalpel
Device Sizes
Device Size - Size Text:
10 Blade
Device Size - Size Type:
Device Size Text, specify