Instrument Cover with PullUp Insert EVCOVER

GUDID 10841912106254

PROTEK MEDICAL PRODUCTS, INC.

Body-surface ultrasound imaging transducer cover Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use

• 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.

• 00841912106691 - Reusable Biopsy Bracket: 2022-06-10 Reusable Biopsy Bracket for Mindray L12-4s, 7L4s, L14-6Ns, L14-6NE & L12-3E Ultrasound Transducers
• 00841912106745 - Biopsy Starter Kit: 2022-06-10 Biopsy Starter Kit for Mindray L12-4s, 7L4s, L14-6Ns, L14-6NE & L12-3E Ultrasound Transducers
• 10841912107107 - Sterile Disposable Endocavity Needle Guide: 2022-04-11 Sterile Disposable Endocavity Needle Guide for Ultrasound Transducers
• 10841912107084 - Sterile Single-Use Probe Cover Kit: 2022-03-21
• 10841912107091 - Sterile Single-Use Surgical Probe Cover Kit: 2022-03-21
• 00841912107049 - Reusable Biopsy Bracket: 2021-12-27 Biospy Bracket for Zonare L10-5 Ultrasound Transducers
• 10841912107053 - General Purpose Probe Cover: 2021-12-27
• 00841912107070 - Biopsy Starter Kit: 2021-12-27 Biopsy Starter Kit for Zonare L10-5 Ultrasound Transducers