Sterile Single-Use Multi-Angle Needle Guide-Probe Cover Kit 5364

GUDID 10841912106902

Sterile Single-Use Multi-Angle Needle Guide-Probe Cover Kit for use with DBSI2C for Esaote SI2C41 Ultrasound Transducers

PROTEK MEDICAL PRODUCTS, INC.

Nonimplantable needle guide, single-use

• Primary Device ID: 10841912106902
• NIH Device Record Key: 85be8e01-bf80-4a76-9530-5e1faef820c5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sterile Single-Use Multi-Angle Needle Guide-Probe Cover Kit
• Version Model Number: 5364
• Catalog Number: 5364
• 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	00841912106905 [Primary]
GS1	10841912106902 [Package]; Contains: 00841912106905; 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: 2021-05-25
• Device Publish Date: 2021-05-17

On-Brand Devices [Sterile Single-Use Multi-Angle Needle Guide-Probe Cover Kit]

• 10841912106919: Sterile Single-Use Multi-Angle Needle Guide-Probe Cover Kit for use with DBSI2C for Esaote SI2C4
• 10841912106902: Sterile Single-Use Multi-Angle Needle Guide-Probe Cover Kit for use with DBSI2C for Esaote SI2C4
• 10841912106896: Sterile Single-Use Multi-Angle Needle Guide-Probe Cover Kit for use with DBSI2C for Esaote SI2C4
• 10841912106889: Sterile Single-Use Multi-Angle Needle Guide-Probe Cover Kit for use with DBSI2C for Esaote SI2C4