Lip Support Disposable Cover

GUDID 06430035873432

PaloDEx Group Oy

Medical equipment drape, single-use, non-sterile

• Primary Device ID: 06430035873432
• NIH Device Record Key: fa72605d-74c5-4906-9cc9-ac5b0159ea7a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lip Support Disposable Cover
• Version Model Number: 901011
• Company DUNS: 459955188
• Company Name: PaloDEx Group Oy
• 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: false
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• 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	06430035873432 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180947

FDA Product Code

• PEM: Dental Barriers And Sleeves

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-02-10
• Device Publish Date: 2020-02-01

On-Brand Devices [Lip Support Disposable Cover]

• 06430035873470: 6801130
• 06430035873432: 901011