PullUp Instrument Cover 1042

GUDID 10841912106063

PROTEK MEDICAL PRODUCTS, INC.

Body-surface ultrasound imaging transducer cover

• Primary Device ID: 10841912106063
• NIH Device Record Key: 4977220b-e947-4f95-bd20-5ac535e831e0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PullUp Instrument Cover
• Version Model Number: 1042
• Catalog Number: 1042
• Company DUNS: 965417181
• Company Name: PROTEK MEDICAL PRODUCTS, INC.
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841912106066 [Primary]
GS1	10841912106063 [Package]; Contains: 00841912106066; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K970885

FDA Product Code

• MMP: Cover, Barrier, Protective

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: 2019-05-27
• Device Publish Date: 2019-05-17

On-Brand Devices [PullUp Instrument Cover]

• 10841912100603: 1030
• 00841912100491: 1003
• 10841912106063: 1042