Miracu BI

GUDID 38809407786189

Feeltech Co.,Ltd.

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: 38809407786189
• NIH Device Record Key: 1ae559cc-d30e-4996-98d9-091e7aba76eb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Miracu BI
• Version Model Number: Miracu BI 23Gx90mm
• 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	08809407786188 [Unit of Use]
GS1	18809407786185 [Primary]
GS1	28809407786182 [Package]; Contains: 18809407786185; Package: [10 Units]; In Commercial Distribution
GS1	38809407786189 [Package]; Contains: 28809407786182; Package: [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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2021-02-05
• Device Publish Date: 2019-09-01

On-Brand Devices [Miracu BI]

• 38809407786189: Miracu BI 23Gx90mm
• 38809407786172: Miracu BI 23Gx60mm
• 38809407786165: Miracu BI 21Gx60mm