Non-Sterile Probe Cover Kits

GUDID 00841912104185

PROTEK MEDICAL PRODUCTS, INC.

Body-orifice ultrasound imaging transducer cover, basic, non-sterile

• Primary Device ID: 00841912104185
• NIH Device Record Key: b2a2235f-9560-4aed-8da9-6e52242e1cdb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Non-Sterile Probe Cover Kits
• Version Model Number: 0137
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841912104185 [Primary]
GS1	10841912104182 [Package]; Package: [20 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: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-16

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