Wellead

GUDID 16944932785127

Endoscopic Seal, Type I (adapter)

Well Lead Medical Co.,Ltd

Endoscopic biopsy valve, single-use Endoscopic biopsy valve, single-use Endoscopic biopsy valve, single-use Endoscopic biopsy valve, single-use Endoscopic biopsy valve, single-use Endoscopic biopsy valve, single-use Endoscopic biopsy valve, single-use Endoscopic biopsy valve, single-use Endoscopic biopsy valve, single-use Endoscopic biopsy valve, single-use Endoscopic biopsy valve, single-use Endoscopic biopsy valve, single-use Endoscopic biopsy valve, single-use Endoscopic biopsy valve, single-use

• Primary Device ID: 16944932785127
• NIH Device Record Key: 42dfceef-1018-4778-a7d5-d628a5795405
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Wellead
• Version Model Number: U04D020110
• 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	06944932785120 [Primary]
GS1	16944932785127 [Package]; Contains: 06944932785120; Package: carton [10 Units]; In Commercial Distribution
GS1	26944932785124 [Package]; Package: box [200 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211814

FDA Product Code

• ODC: Endoscope Channel Accessory

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: 2022-02-03
• Device Publish Date: 2022-01-26

On-Brand Devices [Wellead]

• 16944932791876: Cricothyrotomy kit, Type I, Cuffed, 6.0mm DEHP FREE (Sterile)
• 16944932785127: Endoscopic Seal, Type I (adapter)
• 16944932785110: Endoscopic Seal, Type I