hongyun

GUDID 06959435510025

Tangshan Hongyun Healthcare Products Co.,Ltd

Vinyl examination/treatment glove, non-powdered

• Primary Device ID: 06959435510025
• NIH Device Record Key: 785801c2-85cd-4e84-bdf5-0e73bdbebc76
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: hongyun
• Version Model Number: HY02
• Company DUNS: 526963258
• Company Name: Tangshan Hongyun Healthcare Products Co.,Ltd
• Device Count: 100
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: true
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06959435500118 [Primary]
GS1	06959435510025 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K072001

FDA Product Code

• LYZ: Vinyl Patient Examination Glove

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: 2020-06-29
• Device Publish Date: 2020-06-20

On-Brand Devices [hongyun]

• 06959435510025: HY02
• 06959435510018: HY02
• 06959435510032: HY02