Rejubeau FCL FORTE 19G x 70mm

GUDID 28800145513719

Feeltech Co.,Ltd.

Polyester suture, bioabsorbable, monofilament, non-antimicrobial

• Primary Device ID: 28800145513719
• NIH Device Record Key: c30c2a89-ba8b-4e15-9c67-de55a3f230ba
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rejubeau FCL FORTE 19G x 70mm
• Version Model Number: 3BE19071620G
• Company DUNS: 688432407
• Company Name: Feeltech Co.,Ltd.
• Device Count: 10
• 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	08800145513715 [Unit of Use]
GS1	18800145513712 [Primary]
GS1	28800145513719 [Package]; Contains: 18800145513712; Package: inbox [10 Units]; In Commercial Distribution
GS1	38800145513716 [Package]; Package: carton box [300 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172602

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: 2024-10-24
• Device Publish Date: 2024-10-16

Devices Manufactured by Feeltech Co.,Ltd.

• 28800145520687 - V-Soft Line BARB STAR 19Gx90mm FDA: 2026-02-02
• 28800145520731 - V-Soft Line BARB STAR 21Gx90mm FDA: 2026-02-02
• 28800145521370 - V-Soft Line BARB STAR 19Gx100mm FDA: 2026-02-02
• 28800145521530 - V-Soft Line BARB BLUNT CANNULA L 21Gx90mm FDA: 2026-02-02
• 28800145521653 - V-Soft Line BARB BLUNT CANNULA N 19Gx100mm FDA: 2026-02-02
• 28800145521974 - V-Soft Line ARTE 18Gx100mm FDA: 2026-02-02
• 28800145522056 - V-Soft Line ARTE 19Gx100mm FDA: 2026-02-02
• 28800145522414 - V-Soft Line ARTE3 17Gx70mm FDA: 2026-02-02