V-Loc 90 Delta VLOCDM0114

GUDID 08809766324861

Absorbable Wound Closure Device

Samyang Holdings Corporation

Barbed polyester suture, non-antimicrobial Barbed polyester suture, non-antimicrobial Barbed polyester suture, non-antimicrobial Barbed polyester suture, non-antimicrobial Barbed polyester suture, non-antimicrobial Barbed polyester suture, non-antimicrobial Barbed polyester suture, non-antimicrobial Barbed polyester suture, non-antimicrobial Barbed polyester suture, non-antimicrobial Barbed polyester suture, non-antimicrobial Barbed polyester suture, non-antimicrobial Barbed polyester suture, non-antimicrobial Barbed polyester suture, non-antimicrobial Barbed polyester suture, non-antimicrobial

• Primary Device ID: 08809766324861
• NIH Device Record Key: 53b25392-eb15-4bca-9381-80dd1425e695
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: V-Loc 90 Delta
• Version Model Number: VLOCDM0114
• Catalog Number: VLOCDM0114
• Company DUNS: 695439951
• Company Name: Samyang Holdings Corporation
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +82221579833
• Email: hongsik.kim@samyang.com
• Phone: +82221579833
• Email: hongsik.kim@samyang.com
• Phone: +82221579833
• Email: hongsik.kim@samyang.com
• Phone: +82221579833
• Email: hongsik.kim@samyang.com
• Phone: +82221579833
• Email: hongsik.kim@samyang.com
• Phone: +82221579833
• Email: hongsik.kim@samyang.com
• Phone: +82221579833
• Email: hongsik.kim@samyang.com
• Phone: +82221579833
• Email: hongsik.kim@samyang.com
• Phone: +82221579833
• Email: hongsik.kim@samyang.com
• Phone: +82221579833
• Email: hongsik.kim@samyang.com
• Phone: +82221579833
• Email: hongsik.kim@samyang.com
• Phone: +82221579833
• Email: hongsik.kim@samyang.com
• Phone: +82221579833
• Email: hongsik.kim@samyang.com
• Phone: +82221579833
• Email: hongsik.kim@samyang.com

Device Dimensions

• Device Size Text, specify: 0
• Length: 12 Inch
• Device Size Text, specify: 0
• Length: 12 Inch
• Device Size Text, specify: 0
• Length: 12 Inch
• Device Size Text, specify: 0
• Length: 12 Inch
• Device Size Text, specify: 0
• Length: 12 Inch
• Device Size Text, specify: 0
• Length: 12 Inch
• Device Size Text, specify: 0
• Length: 12 Inch
• Device Size Text, specify: 0
• Length: 12 Inch
• Device Size Text, specify: 0
• Length: 12 Inch
• Device Size Text, specify: 0
• Length: 12 Inch
• Device Size Text, specify: 0
• Length: 12 Inch
• Device Size Text, specify: 0
• Length: 12 Inch
• Device Size Text, specify: 0
• Length: 12 Inch
• Device Size Text, specify: 0
• Length: 12 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809766324854 [Primary]
GS1	08809766324861 [Package]; Contains: 08809766324854; Package: Carton [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212810

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-08
• Device Publish Date: 2023-05-31

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