Vilet™ V386U

GUDID 20841307130588

Vilet PGLA 4/0 C-3 [3/8C RevCt 13mm] 18” Undyed

IMPLANT DIRECT SYBRON MANUFACTURING LLC

Polyester suture, bioabsorbable, multifilament, non-antimicrobial

• Primary Device ID: 20841307130588
• NIH Device Record Key: 088baa40-7259-47d4-9a8e-242a0dbede7c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vilet™
• Version Model Number: V386U
• Catalog Number: V386U
• Company DUNS: 868856969
• Company Name: IMPLANT DIRECT SYBRON MANUFACTURING 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-888-649-6425
• Email: customerservice@implantdirect.com
• Phone: 1-888-649-6425
• Email: customerservice@implantdirect.com
• Phone: 1-888-649-6425
• Email: customerservice@implantdirect.com
• Phone: 1-888-649-6425
• Email: customerservice@implantdirect.com
• Phone: 1-888-649-6425
• Email: customerservice@implantdirect.com
• Phone: 1-888-649-6425
• Email: customerservice@implantdirect.com
• Phone: 1-888-649-6425
• Email: customerservice@implantdirect.com
• Phone: 1-888-649-6425
• Email: customerservice@implantdirect.com
• Phone: 1-888-649-6425
• Email: customerservice@implantdirect.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	10841307130581 [Primary]
GS1	20841307130588 [Package]; Contains: 10841307130581; Package: Chipboard Carton [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: 6
• Public Version Date: 2021-02-05
• Device Publish Date: 2015-10-16

On-Brand Devices [Vilet™]

• 20841307130632: Vilet PGLA 3/0 FS-2 [3/8C RevCt 19mm] 18” Undyed
• 20841307130625: Vilet PGLA 3/0 FS-2 [3/8C RevCt 19mm] 18” Violet
• 20841307130618: Vilet PGLA 4/0 FS-2 [3/8C RevCt 19mm] 18” Undyed (Sample 2pk)
• 20841307130601: Vilet PGLA 4/0 FS-2 [3/8C RevCt 19mm] 18” Undyed
• 20841307130595: Vilet PGLA 4/0 FS-2 [3/8C RevCt 19mm] 18” Violet
• 20841307130588: Vilet PGLA 4/0 C-3 [3/8C RevCt 13mm] 18” Undyed
• 20841307130571: Vilet PGLA 5/0 C-3 [3/8C RevCt 13mm] 18” Undyed