Disposable Needle Guide

GUDID 00841912106622

PROTEK MEDICAL PRODUCTS, INC.

Nonimplantable needle guide, single-use

• Primary Device ID: 00841912106622
• NIH Device Record Key: 883f880b-8ef1-485f-9c79-4892e942f29f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Disposable Needle Guide
• Version Model Number: 5480
• Company DUNS: 965417181
• Company Name: PROTEK MEDICAL PRODUCTS, INC.
• Device Count: 250
• 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: false
• Expiration Date: false
• 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	00841912106622 [Unit of Use]
GS1	10841912106629 [Primary]

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: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-09-09
• Device Publish Date: 2020-06-01

On-Brand Devices [Disposable Needle Guide]

• 20841912104059: 5055
• 10841912105943: 5560
• 10841912105875: 5070
• 10841912105455: 5285
• 10841912104939: 5145
• 10841912104922: 5154
• 10841912104915: 5250
• 10841912104908: 5144
• 10841912104892: 9000
• 10841912104885: 5531
• 10841912104052: 5065
• 00841912106455: 5445
• 00841912106622: 5480