FILBLOC

GUDID 18033439115587

ASSUT EUROPE SPA

Polyester suture, bioabsorbable, monofilament, non-antimicrobial

• Primary Device ID: 18033439115587
• NIH Device Record Key: 9bce2437-a5bb-413c-a8d7-b233263d553f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FILBLOC
• Version Model Number: FS412HHAB
• 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	18033439115587 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-06-13
• Device Publish Date: 2024-06-05

On-Brand Devices [FILBLOC]

• 18033439160884: FS028HHAC
• 18033439183784: FV373HHAA
• 18033439133253: FU400HHAB
• 18033439195886: FS77CHHAA
• 18033439183715: FU400HHAA
• 18033439133284: FV373HHAB
• 18033439150007: FR438HHAC
• 18033439147410: FR465HHAC
• 18033439133628: FU395HHAD
• 18033439117840: FS412HHAE
• 18033439115587: FS412HHAB
• 18033439115570: FU395HHAB
• 18033439114030: FU395HHAE
• 18033439374106: FU38EHHAH
• 18033439374090: FU534HHAP
• 18033439168712: FQ478HHAH
• 18033439114085: FS412HHAH
• 08033439416731: FS248HHAD/3