Rejubeau Fine Meso Needle 32G x 13mm

GUDID 28800145508616

Feeltech Co.,Ltd.

Polyester suture, bioabsorbable, monofilament, non-antimicrobial

• Primary Device ID: 28800145508616
• NIH Device Record Key: a9ccf346-7875-47a7-a39c-630858d77577
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rejubeau Fine Meso Needle 32G x 13mm
• Version Model Number: FDND 54
• Company DUNS: 688432407
• Company Name: Feeltech Co.,Ltd.
• Device Count: 100
• 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	08800145508612 [Unit of Use]
GS1	18800145508619 [Primary]
GS1	28800145508616 [Package]; Contains: 18800145508619; Package: outbox [1000 Units]; In Commercial Distribution
GS1	38800145508613 [Package]; Package: carton box [5000 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172602

FDA Product Code

• FMI: Needle, Hypodermic, Single Lumen
• 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: 2024-05-17
• Device Publish Date: 2024-05-09

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