Non-Sterile Probe Storage Covers

GUDID 80841912104266

PROTEK MEDICAL PRODUCTS, INC.

Body-surface ultrasound imaging transducer cover

• Primary Device ID: 80841912104266
• NIH Device Record Key: af90248d-9b57-4a00-af44-65e8a3dd7156
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Non-Sterile Probe Storage Covers
• Version Model Number: 1160
• Company DUNS: 965417181
• Company Name: PROTEK MEDICAL PRODUCTS, INC.
• Device Count: 100
• 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: false
• 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	00841912104260 [Unit of Use]
GS1	70841912104269 [Primary]
GS1	80841912104266 [Package]; Contains: 70841912104269; Package: [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K970889

FDA Product Code

• KKX: Drape, Surgical

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: 2020-12-14
• Device Publish Date: 2020-12-04

On-Brand Devices [Non-Sterile Probe Storage Covers]

• 40841912104268: 1160
• 60841912104262: 1160
• 80841912104266: 1160