Model: MT2
DI: 00850040983043
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: No
OTC: No
First Published: 2026-05-20
Current Version: 2026-05-28
Distribution End: 2026-05-20
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
fb0266ac-44df-41da-8e52-2ebf13dd0e46
Distribution Status:
Not in Commercial Distribution
DUNS Number:
080704335
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:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00850040983043
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 16866
Name: Dressing-fixation skin adhesive tape, non-silicone
Definition:
A long and narrow flexible band of non-silicone-based material (e.g., fabric, plastic, paper) coated on one or both sides with a pressure-sensitive adhesive, intended to non-invasively adhere to the skin surface to fix a dressing in place or attach objects (e.g., catheter, lamp); it might have hypoallergenic and/or waterproof properties. This is a single-use device.
FDA Product Codes
KGX
Tape And Bandage, Adhesive