VILET Q

GUDID 10812444021766

SUTURE

RIVERPOINT MEDICAL, LLC

Polyester suture, bioabsorbable, multifilament Polyester suture, bioabsorbable, multifilament Polyester suture, bioabsorbable, multifilament, non-antimicrobial Polyester suture, bioabsorbable, multifilament, non-antimicrobial Polyester suture, bioabsorbable, multifilament, non-antimicrobial Polyester suture, bioabsorbable, multifilament, non-antimicrobial Polyester suture, bioabsorbable, multifilament, non-antimicrobial Polyester suture, bioabsorbable, multifilament, non-antimicrobial Polyester suture, bioabsorbable, multifilament, non-antimicrobial Polyester suture, bioabsorbable, multifilament, non-antimicrobial Polyester suture, bioabsorbable, multifilament, non-antimicrobial Polyester suture, bioabsorbable, multifilament, non-antimicrobial Polyester suture, bioabsorbable, multifilament, non-antimicrobial

• Primary Device ID: 10812444021766
• NIH Device Record Key: 0dc01f07-f0e5-4e00-a0a4-cf50be744e38
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VILET Q
• Version Model Number: VQ497
• Company DUNS: 964053560
• Company Name: RIVERPOINT MEDICAL, LLC
• 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: true
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812444021769 [Primary]
GS1	10812444021766 [Package]; Contains: 00812444021769; Package: [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120556

FDA Product Code

• GAM: Suture, Absorbable, Synthetic, Polyglycolic Acid

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: 2019-10-14
• Device Publish Date: 2015-10-23

Devices Manufactured by RIVERPOINT MEDICAL, LLC

• 10812444029441 - HS FIber: 2024-06-26 Suture Tape
• 00810020080285 - OrthoButton CL: 2024-05-24 Continuous Loop with Titanium Button
• 00810020080292 - OrthoButton CL: 2024-05-24 Continuous Loop with Titanium Button
• 00810020080308 - OrthoButton CL: 2024-05-24 Continuous Loop with Titanium Button
• 00810020080315 - OrthoButton CL: 2024-05-24 Continuous Loop with Titanium Button
• 00810020080322 - OrthoButton CL: 2024-05-24 Continuous Loop with Titanium Button
• 00810020080360 - OrthoButton CL: 2024-05-24 Continuous Loop with Titanium Button
• 00810020083576 - OrthoButton CL: 2024-05-24 Continuous Loop with Titanium Button