REJUBEAU FCN 4D 19G x 100mm (W-shape)

GUDID 28800145513375

Feeltech Co.,Ltd.

Polyester suture, bioabsorbable, monofilament, non-antimicrobial

• Primary Device ID: 28800145513375
• NIH Device Record Key: 793460e8-d457-4799-8607-c75035783926
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: REJUBEAU FCN 4D 19G x 100mm (W-shape)
• Version Model Number: W4-FTN1911G
• 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	08800145513371 [Unit of Use]
GS1	18800145513378 [Primary]
GS1	28800145513375 [Package]; Contains: 18800145513378; Package: outbox [10 Units]; In Commercial Distribution
GS1	38800145513372 [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: 2024-07-18
• Device Publish Date: 2024-07-10

Devices Manufactured by Feeltech Co.,Ltd.

• 28800145513696 - Rejubeau N.Double FORTE 19G x 60mm: 2024-10-24
• 28800145513702 - Rejubeau FCL FORTE 18G x 100mm: 2024-10-24
• 28800145513719 - Rejubeau FCL FORTE 19G x 70mm: 2024-10-24
• 28800145513368 - REJUBEAU FCN 4D 18G x 100mm (W-shape): 2024-07-18
• 28800145513375 - REJUBEAU FCN 4D 19G x 100mm (W-shape): 2024-07-18
• 28800145513375 - REJUBEAU FCN 4D 19G x 100mm (W-shape): 2024-07-18
• 28800145513382 - REJUBEAU FCN 4D 21G x 60mm (W-shape): 2024-07-18
• 28800145508340 - IDryNeedle 0.25x30: 2024-05-17
• 28800145508357 - IDryNeedle 0.25x40: 2024-05-17