Miracu FCL FORTE 19Gx70mm

GUDID 28809407788360

Feeltech Co.,Ltd.

Polyester suture, bioabsorbable, monofilament, non-antimicrobial

• Primary Device ID: 28809407788360
• NIH Device Record Key: 09575bb4-3995-4caf-9688-85d67316321d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Miracu FCL FORTE 19Gx70mm
• 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: false
• 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	08809407788366 [Unit of Use]
GS1	18809407788363 [Primary]
GS1	28809407788360 [Package]; Contains: 18809407788363; Package: INBOX [10 Units]; In Commercial Distribution
GS1	38809407788367 [Package]; Package: CARTONBOX [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: 2020-12-07
• Device Publish Date: 2020-11-29

On-Brand Devices [Miracu FCL FORTE 19Gx70mm]

• 28809407788360: 3BE19071620G
• 28800145524203: 3BE19071620G