E-LOC ENDO 360° BARBED SUTURE

GUDID 18033439168897

ASSUT EUROPE SPA

Polyester suture, bioabsorbable, monofilament

• Primary Device ID: 18033439168897
• NIH Device Record Key: f6a4fb68-b804-4af6-99ed-3df3693ee197
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: E-LOC ENDO 360° BARBED SUTURE
• Version Model Number: ECN-BAR20
• Company DUNS: 654747567
• Company Name: ASSUT EUROPE SPA
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: true
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	18033439168897 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150553

FDA Product Code

• NEW: Suture, Surgical, Absorbable, Polydioxanone

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-02-07
• Device Publish Date: 2017-05-05

On-Brand Devices [E-LOC ENDO 360° BARBED SUTURE]

• 18033439173587: ECN-BAR420
• 18033439168897: ECN-BAR20