ProV-Access Vascular Access Needle Guide 5401SNR

GUDID 10841912105516

PROTEK MEDICAL PRODUCTS, INC.

Nonimplantable needle guide, single-use

• Primary Device ID: 10841912105516
• NIH Device Record Key: d1e0cfff-6b85-4bf6-a7da-0d2ef2f96e7e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ProV-Access Vascular Access Needle Guide
• Version Model Number: 5401
• Catalog Number: 5401SNR
• 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	00841912105519 [Primary]
GS1	10841912105516 [Package]; Contains: 00841912105519; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K973958

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: 4
• Public Version Date: 2019-10-07
• Device Publish Date: 2018-04-27

On-Brand Devices [ProV-Access Vascular Access Needle Guide]

• 10841912105561: 5406
• 10841912105554: 5405
• 10841912105547: 5404
• 10841912105530: 5403
• 10841912105523: 5402
• 10841912105516: 5401