V-Soft Line ARTE2 18Gx100mm FDA

GUDID 28800145522131

Feeltech Co.,Ltd.

Polyester suture, bioabsorbable, monofilament, non-antimicrobial

• Primary Device ID: 28800145522131
• NIH Device Record Key: ac9260b2-68e2-424a-ab4c-c4a86e2c76ae
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: V-Soft Line ARTE2 18Gx100mm FDA
• Version Model Number: 4PS118191603G
• Company DUNS: 688432407
• Company Name: Feeltech Co.,Ltd.
• Device Count: 5
• 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	08800145522137 [Unit of Use]
GS1	18800145522134 [Primary]
GS1	28800145522131 [Package]; Contains: 18800145522134; Package: INBOX [10 Units]; In Commercial Distribution
GS1	38800145522138 [Package]; Package: CARTONBOX [300 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K250107

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: 2026-03-27
• Device Publish Date: 2026-03-19

Devices Manufactured by Feeltech Co.,Ltd.

• 28800145520694 - V-Soft Line BARB STAR 21Gx60mm FDA: 2026-03-27
• 28800145520939 - V-Soft Line BARB BLUNT CANNULA 23Gx60mm FDA: 2026-03-27
• 28800145521134 - V-Soft Line BARB BLUNT CANNULA L 21Gx60mm FDA: 2026-03-27
• 28800145521172 - V-Soft Line BARB BLUNT CANNULA L 21Gx90mm FDA: 2026-03-27
• 28800145521851 - V-Soft Line BARB BLUNT CANNULA L 19Gx40mm FDA: 2026-03-27
• 28800145522131 - V-Soft Line ARTE2 18Gx100mm FDA: 2026-03-27
• 28800145522131 - V-Soft Line ARTE2 18Gx100mm FDA: 2026-03-27
• 28800145522810 - V-Soft Line MONO 27Gx50mm FDA: 2026-03-27
• 28800145523091 - V-Soft Line MONO 29Gx50mm FDA: 2026-03-27