SYLKE

GUDID 00860010416907

Adhesive Wound Closure

Sylke Inc.

Skin-closure adhesive strip

• Primary Device ID: 00860010416907
• NIH Device Record Key: 0f12e42e-228d-4fea-bfbc-8a836dd9dd42
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SYLKE
• Version Model Number: SYL-WC-32
• Company DUNS: 119162524
• Company Name: Sylke Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860010416907 [Primary]

FDA Product Code

• KGX: Tape And Bandage, Adhesive

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-07-16
• Device Publish Date: 2024-07-08