Sterile Disposable Endocavity Needle Guide Kit 5562

GUDID 10841912105271

Sterile Disposable Endocavity Needle Guide Kit for use with Toshiba PVT-781VT, PVU-781VT & 11C3 Ultrasound Transducers

PROTEK MEDICAL PRODUCTS, INC.

Body-orifice ultrasound imaging transducer cover, basic, sterile

• Primary Device ID: 10841912105271
• NIH Device Record Key: 1ab4f264-f6c5-4675-b95e-4e4d86670bfe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sterile Disposable Endocavity Needle Guide Kit
• Version Model Number: 5562
• Catalog Number: 5562
• 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	00841912105274 [Primary]
GS1	10841912105271 [Package]; Contains: 00841912105274; Package: [24 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K970891

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: 6
• Public Version Date: 2019-10-07
• Device Publish Date: 2017-10-06

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