Surgical Probe Cover Kit 1237

GUDID 10841912104755

PROTEK MEDICAL PRODUCTS, INC.

Cable/lead/sensor/probe cover, sterile Intraoperative ultrasound imaging transducer cover Intraoperative ultrasound imaging transducer cover Intraoperative ultrasound imaging transducer cover Intraoperative ultrasound imaging transducer cover Intraoperative ultrasound imaging transducer cover Intraoperative ultrasound imaging transducer cover Intraoperative ultrasound imaging transducer cover Intraoperative ultrasound imaging transducer cover Intraoperative ultrasound imaging transducer cover Intraoperative ultrasound imaging transducer cover Intraoperative ultrasound imaging transducer cover Intraoperative ultrasound imaging transducer cover Intraoperative ultrasound imaging transducer cover Intraoperative ultrasound imaging transducer cover Intraoperative ultrasound imaging transducer cover Intraoperative ultrasound imaging transducer cover

• Primary Device ID: 10841912104755
• NIH Device Record Key: 2c0909bb-239e-492d-a414-7771e7b5236e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Surgical Probe Cover Kit
• Version Model Number: 1237
• Catalog Number: 1237
• 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	00841912104758 [Primary]
GS1	10841912104755 [Package]; Contains: 00841912104758; 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: 2017-02-17

On-Brand Devices [Surgical Probe Cover Kit]

• 10841912104755: 1237
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• 10841912100795: 1930
• 10841912100788: 1930
• 10841912100771: 1929
• 10841912106537: 1946