Miracu FCL FORTE 19Gx100mm

GUDID 28800145524210

Feeltech Co.,Ltd.

Polyester suture, bioabsorbable, monofilament, non-antimicrobial

• Primary Device ID: 28800145524210
• NIH Device Record Key: 8cf76c32-3430-4203-9a35-c8c0fc701327
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Miracu FCL FORTE 19Gx100mm
• Version Model Number: 3BE19101820G
• 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	08800145524216 [Unit of Use]
GS1	18800145524213 [Primary]
GS1	28800145524210 [Package]; Contains: 18800145524213; Package: INBOX [10 Units]; In Commercial Distribution
GS1	38800145524217 [Package]; Package: CARTON BOX [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: 2026-03-06
• Device Publish Date: 2026-02-26

Devices Manufactured by Feeltech Co.,Ltd.

• 28800145524197 - Miracu FCL FORTE 18Gx100mm: 2026-03-06
• 28800145524203 - Miracu FCL FORTE 19Gx70mm: 2026-03-06
• 28800145524210 - Miracu FCL FORTE 19Gx100mm: 2026-03-06
• 28800145524210 - Miracu FCL FORTE 19Gx100mm: 2026-03-06
• 28800145524265 - Miracu FCL FORTE FIX 18Gx100mm: 2026-03-06
• 28800145524272 - Miracu FCL FORTE FIX 19Gx70mm: 2026-03-06
• 28800145524302 - Miracu FCV Line 17Gx70mm: 2026-03-06
• 28800145524319 - iracu FCV Line 17Gx100mm: 2026-03-06
• 28800145524395 - Miracu MONO 27Gx40mm FDA: 2026-03-06