WEGO-SILK Non-absorbable Surgical Suture With Needle

GUDID 16941813681417

Foosin Medical Supplies Inc., Ltd.

Silk suture

• Primary Device ID: 16941813681417
• NIH Device Record Key: 7b6ad2b8-3efc-462e-8e0c-a48c78d983ae
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WEGO-SILK Non-absorbable Surgical Suture With Needle
• Version Model Number: S33242-45
• Company DUNS: 528180159
• Company Name: Foosin Medical Supplies Inc., 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 Identifiers

Device Issuing Agency	Device ID
GS1	06941813681410 [Primary]
GS1	16941813681417 [Package]; Contains: 06941813681410; Package: [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080684

FDA Product Code

• GAP: Suture, Nonabsorbable, Silk

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: 2022-12-09
• Device Publish Date: 2022-12-01

On-Brand Devices [WEGO-SILK Non-absorbable Surgical Suture With Needle]

• 06941813659013: S46193-45
• 06941813659006: S36193-45
• 06941813659037: S26263-45
• 06941813659020: S36263-45
• 06941813658917: SC3453
• 06941813656623: S31222
• 16941813681417: S33242-45