Sterile Disposable Endocavity Needle Guide 5295

GUDID 10841912105721

Sterile Disposable Endocavity Needle Guide for use with Samsung EA2-11B Ultrasound Transducers

PROTEK MEDICAL PRODUCTS, INC.

Nonimplantable needle guide, single-use

• Primary Device ID: 10841912105721
• NIH Device Record Key: 03d44e06-25f2-467c-96ca-75712a3760fc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sterile Disposable Endocavity Needle Guide
• Version Model Number: 5295
• Catalog Number: 5295
• 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	00841912105724 [Primary]
GS1	10841912105721 [Package]; Contains: 00841912105724; Package: [24 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K971115

FDA Product Code

• ITX: Transducer, Ultrasonic, Diagnostic

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: 2019-10-07
• Device Publish Date: 2018-08-17

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