Device
SYL-WC-32
Manufacturer
Sylke Inc.
Model: SYL-WC-32 DI: 00850081866008 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
Sterilization
Device Sterile: Yes
Sterilization Prior To Use: No
Regulatory & Distribution
Record Status: Published
Version Number: 1
Record Key: c5becd2f-ecf2-4f7f-8e11-9f0286bc78aa
Distribution Status: In Commercial Distribution
DUNS Number: 119162524
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: No
Identifiers
Device ID: 00850081866008
Type: Primary
Issuing Agency: GS1
GMDN
Code: 32207
Name: Skin-closure adhesive strip
Definition:
A small, narrow flexible band (of fabric, plastic, paper, or other material) coated on one side with a pressure-sensitive adhesive, used to approximate the edges of superficial wounds. The device may be hypoallergenic and/or waterproof. This is a single-use device.
FDA Product Codes
KGX
Tape And Bandage, Adhesive