FILBLOC PERMANENT

GUDID 18033439178889

ASSUT EUROPE SPA

Polyolefin suture, monofilament

• Primary Device ID: 18033439178889
• NIH Device Record Key: 96908f85-8cdf-4565-a120-248a16c73c36
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FILBLOC PERMANENT
• Version Model Number: PLY-G02-020-A
• 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	18033439178889 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171039

FDA Product Code

• GAW: Suture, Nonabsorbable, Synthetic, Polypropylene

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: 2019-03-11
• Device Publish Date: 2019-02-28

On-Brand Devices [FILBLOC PERMANENT]

• 18033439180042: PLY-G02-020-APL
• 18033439178889: PLY-G02-020-A
• 18033439169238: PS028HHAC
• 18033439164295: PU693IHBQ
• 38033439008968: PU543
• 38033439007770: PY893K
• 38033439007435: PS920
• 38033439007190: PY891
• 38033439007138: PZ890