Instrument Cover with PullUp Insert EVCOVER

GUDID 10841912106254

PROTEK MEDICAL PRODUCTS, INC.

Body-surface ultrasound imaging transducer cover

• Primary Device ID: 10841912106254
• NIH Device Record Key: c59d6f38-668c-4656-8bb8-e73a2cb3c020
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Instrument Cover with PullUp Insert
• Version Model Number: 1036
• Catalog Number: EVCOVER
• 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	00841912106257 [Primary]
GS1	10841912106254 [Package]; Contains: 00841912106257; Package: [25 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K970885
• Premarket Notification: K970889

FDA Product Code

• KKX: Drape, Surgical
• 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: 2020-03-23
• Device Publish Date: 2020-03-13

Devices Manufactured by PROTEK MEDICAL PRODUCTS, INC.

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• 10841912106520 - Sterile Protective Barrier Kit: 2024-07-25
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• 10841912107107 - Sterile Disposable Endocavity Needle Guide: 2022-04-11 Sterile Disposable Endocavity Needle Guide for Ultrasound Transducers