Sterile Disposable Endocavity Needle Guide Kit 5535

GUDID 10841912106346

Sterile Disposable Endocavity Needle Guide Kit for use with Canon-Toshiba PVF-621VT, PVF-641VT, PVF-651VT, PVG-601V, PWM-651VT, PVN-661VT, PVT-661VT & PVQ-641V, and Siemens EC9-4 (Acuson S2000 & Sonoline Antares Ultrasound Systems) Ultrasound Transducers

PROTEK MEDICAL PRODUCTS, INC.

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• Primary Device ID: 10841912106346
• NIH Device Record Key: 9bba5a2b-ada8-4fc3-8e72-4eaec16b7967
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sterile Disposable Endocavity Needle Guide Kit
• Version Model Number: 5535
• Catalog Number: 5535
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841912106349 [Primary]
GS1	10841912106346 [Package]; Contains: 00841912106349; Package: [24 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K970893

FDA Product Code

• ITX: Transducer, Ultrasonic, Diagnostic

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

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