General Purpose Probe Cover VPC5536

GUDID 10841912107053

PROTEK MEDICAL PRODUCTS, INC.

Body-surface ultrasound imaging transducer cover

• Primary Device ID: 10841912107053
• NIH Device Record Key: 52e5c634-6061-4c91-83cf-4516da92994f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: General Purpose Probe Cover
• Version Model Number: 2323
• Catalog Number: VPC5536
• 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: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841912107056 [Primary]
GS1	10841912107053 [Package]; Contains: 00841912107056; Package: [24 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K970893

FDA Product Code

• KKX: Drape, Surgical

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: 2021-12-27
• Device Publish Date: 2021-12-17

On-Brand Devices [General Purpose Probe Cover]

• 00841912100125: 2008
• 00841912100118: 2007
• 10841912107053: 2323