Scanning Cover 1035

GUDID 10841912100610

PROTEK MEDICAL PRODUCTS, INC.

Instrument/equipment drape, single-use, sterile Body-surface ultrasound imaging transducer cover Body-surface ultrasound imaging transducer cover Body-surface ultrasound imaging transducer cover Body-surface ultrasound imaging transducer cover Body-surface ultrasound imaging transducer cover Body-surface ultrasound imaging transducer cover Body-surface ultrasound imaging transducer cover Body-surface ultrasound imaging transducer cover Body-surface ultrasound imaging transducer cover Body-surface ultrasound imaging transducer cover Body-surface ultrasound imaging transducer cover Body-surface ultrasound imaging transducer cover Body-surface ultrasound imaging transducer cover Body-surface ultrasound imaging transducer cover Body-surface ultrasound imaging transducer cover Body-surface ultrasound imaging transducer cover

• Primary Device ID: 10841912100610
• NIH Device Record Key: ef575a8f-b807-4483-9d4a-668b1ca07d9e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Scanning Cover
• Version Model Number: 1035
• Catalog Number: 1035
• 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	00841912100613 [Primary]
GS1	10841912100610 [Package]; Contains: 00841912100613; Package: [100 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: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-16

Devices Manufactured by PROTEK MEDICAL PRODUCTS, INC.

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• 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