MIXPAC Protective Sleeve PRS 801-03

GUDID 07350069420763

MIXPAC™ Protective Sleeves provide convenient and effective barrier protection of multi-use application systems to protect the dentist, staff and patient against cross-contamination and infectious disease during clinical use.

Minitube AB

Medical equipment drape, single-use

• Primary Device ID: 07350069420763
• NIH Device Record Key: e7d3ddc1-9145-4c07-b255-979db0f77194
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MIXPAC Protective Sleeve
• Version Model Number: 50 ml
• Catalog Number: PRS 801-03
• Company DUNS: 775295061
• Company Name: Minitube AB
• Device Count: 300
• 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: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• 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	07350069420763 [Unit of Use]
GS1	07350069421760 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211026

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: 2022-10-11
• Device Publish Date: 2022-10-03

On-Brand Devices [MIXPAC Protective Sleeve]

• 07350069420787: MIXPAC™ Protective Sleeves provide convenient and effective barrier protection of multi-use ap
• 07350069420770: MIXPAC™ Protective Sleeves provide convenient and effective barrier protection of multi-use ap
• 07350069420763: MIXPAC™ Protective Sleeves provide convenient and effective barrier protection of multi-use ap