Well Lead Extraction Bag

GUDID 16944932741185

Type C 550ml

Well Lead Medical Co.,Ltd

Surgical tissue/fluid collection bag

• Primary Device ID: 16944932741185
• NIH Device Record Key: 6d19b2b5-6b17-41b9-93e8-5e6e9d644f8d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Well Lead Extraction Bag
• Version Model Number: O02A030510
• Company DUNS: 544811862
• Company Name: Well Lead 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 Identifiers

Device Issuing Agency	Device ID
GS1	06944932741188 [Primary]
GS1	16944932741185 [Package]; Contains: 06944932741188; Package: Box [5 Units]; In Commercial Distribution
GS1	26944932741182 [Package]; Package: Carton [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160801

FDA Product Code

• GCJ: Laparoscope, General & Plastic Surgery

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: 2023-07-20
• Device Publish Date: 2023-07-12

On-Brand Devices [Well Lead Extraction Bag]

• 16944932741192: Type C 300ml
• 16944932741185: Type C 550ml
• 16944932741178: Type C 800ml
• 06944932741157: Type B 300ml
• 16936881166492: Type E 2500ml
• 06936881166488: Type D 200ml
• 16936881133777: Type B 800ml
• 16936881133760: Type B 550ml
• 06936881133756: Type A 800ml
• 16936881133746: Type A 400ml
• 06936881133725: Type A 200ml