Miracu

GUDID 38809407786646

Feeltech Co.,Ltd.

Polyester suture, bioabsorbable, monofilament

• Primary Device ID: 38809407786646
• NIH Device Record Key: 008f6652-b0d8-427f-9f64-e8de80b213ba
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Miracu
• Version Model Number: Miracu FCL FORTE 19Gx100mm
• 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	08809407786645 [Unit of Use]
GS1	18809407786642 [Primary]
GS1	28809407786649 [Package]; Contains: 18809407786642; Package: IN BOX [10 Units]; In Commercial Distribution
GS1	38809407786646 [Package]; Contains: 28809407786649; Package: C/T 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: 2019-11-13
• Device Publish Date: 2019-11-05

On-Brand Devices [Miracu]

• 38809407786646: Miracu FCL FORTE 19Gx100mm
• 38809407786639: Miracu FCL FORTE 18Gx100mm
• 38809407786622: Miracu FCN BI 19Gx90mm
• 38809407786615: Miracu FC BI 21Gx60mm