Model: MT-A-50
DI: 16975808860174
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: No
OTC: No
First Published: 2026-05-13
Current Version: 2026-05-21
Sterilization
Item #1:
Ethylene Oxide
Item #2:
Hydrogen Peroxide
Device Sterile:
No
Sterilization Prior To Use:
Yes
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
11c20f45-d7f7-442a-9bc0-9d04d6232ae6
Distribution Status:
In Commercial Distribution
DUNS Number:
414588331
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
Yes
Identifiers
Device ID:
16975808860174
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 35134
Name: Dermatome blade, single-use
Definition:
A surgical cutting device that is designed to be mounted onto a dermatome handle/handpiece (not included) and used to provide the cutting edge for the harvesting of skin grafts or excision of small skin lesions. It is available in various sizes. This is a single-use device.
FDA Product Codes
GFD
Dermatome