DW-1C

GUDID 08800050100000

DongWon Medical CO.,LTD.

Polyester suture, bioabsorbable, monofilament, non-antimicrobial

• Primary Device ID: 08800050100000
• NIH Device Record Key: e31ead0c-8da8-4b25-af33-fc02b6110e9b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DW-1C
• Version Model Number: DWFA-1C
• Company DUNS: 690412950
• Company Name: DongWon Medical CO.,LTD.
• Device Count: 1
• 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: true
• OTC Over-The-Counter: false

Device Dimensions

• Length: 43 Centimeter
• Length: 43 Centimeter
• Length: 43 Centimeter
• Length: 43 Centimeter
• Length: 43 Centimeter
• Length: 43 Centimeter
• Length: 43 Centimeter
• Length: 43 Centimeter
• Length: 43 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800050100000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160761

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: 2019-03-20