WEGO-Polypropylene Nonabsorbable Surgical Suture With Needle

GUDID 06941813678434

Foosin Medical Supplies Inc., Ltd.

Polyolefin suture, monofilament

• Primary Device ID: 06941813678434
• NIH Device Record Key: d801eb01-5feb-4f8a-90fd-dd9c39151ed1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WEGO-Polypropylene Nonabsorbable Surgical Suture With Needle
• Version Model Number: P66133-45
• Company DUNS: 528180159
• Company Name: Foosin Medical Supplies Inc., Ltd.
• Device Count: 1
• DM Exempt: true
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06941813673439 [Primary]
GS1	06941813678434 [Package]; Contains: 06941813673439; Package: [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080684

FDA Product Code

• GAW: Suture, Nonabsorbable, Synthetic, Polypropylene

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: 2020-09-02
• Device Publish Date: 2020-08-25

On-Brand Devices [WEGO-Polypropylene Nonabsorbable Surgical Suture With Needle]

• 06941813678465: P36193-45
• 06941813678458: P46163-45
• 06941813678441: P56163-45
• 06941813678434: P66133-45