Miracu FCL BI 18Gx100mm

GUDID 28809407787097

Feeltech Co.,Ltd.

Polyester suture, bioabsorbable, monofilament Polyester suture, bioabsorbable, monofilament, non-antimicrobial Polyester suture, bioabsorbable, monofilament, non-antimicrobial Polyester suture, bioabsorbable, monofilament, non-antimicrobial Polyester suture, bioabsorbable, monofilament, non-antimicrobial Polyester suture, bioabsorbable, monofilament, non-antimicrobial Polyester suture, bioabsorbable, monofilament, non-antimicrobial Polyester suture, bioabsorbable, monofilament, non-antimicrobial Polyester suture, bioabsorbable, monofilament, non-antimicrobial Polyester suture, bioabsorbable, monofilament, non-antimicrobial

• Primary Device ID: 28809407787097
• NIH Device Record Key: 091c8a3f-1029-40ea-862d-3aafe2e48484
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Miracu FCL BI 18Gx100mm
• Version Model Number: L-FTN1811G
• 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	08809407787093 [Unit of Use]
GS1	18809407787090 [Primary]
GS1	28809407787097 [Package]; Contains: 18809407787090; Package: INBOX [10 Units]; In Commercial Distribution
GS1	38809407787094 [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: 2020-03-05
• Device Publish Date: 2020-02-26

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• 28800145507909 - Rejubeau Stylish FCN Forte Double 19G x 100mm (W-shape): 2023-12-28
• 28800145507916 - Rejubeau Stylish FCV Line 17G x 100mm: 2023-12-28
• 28800145507923 - Rejubeau Stylish FCL Forte Fix 19G x 100mm (L-shape): 2023-12-28
• 28800145507930 - Rejubeau Stylish FCN V UP Shark 19G x 100mm (W-shape): 2023-12-28