Sterile Disposable Needle Guide Kit 5017

GUDID 10841912106117

Sterile Disposable Endocavity Needle Guide Kit for use with GE BE9C Ultrasound Transducers

PROTEK MEDICAL PRODUCTS, INC.

Body-orifice ultrasound imaging transducer cover, basic, sterile

• Primary Device ID: 10841912106117
• NIH Device Record Key: 7716b565-f628-4fe4-b8f9-6775d1e2b748
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sterile Disposable Needle Guide Kit
• Version Model Number: 5017
• Catalog Number: 5017
• 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: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841912106110 [Primary]
GS1	10841912106117 [Package]; Contains: 00841912106110; 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: 2
• Public Version Date: 2019-10-07
• Device Publish Date: 2019-06-14

Devices Manufactured by PROTEK MEDICAL PRODUCTS, INC.

• 10841912106049 - System Cover: 2024-07-25
• 10841912106490 - Sterile Protective Barrier Kit: 2024-07-25
• 10841912106506 - Sterile Protective Barrier Kit: 2024-07-25
• 10841912106513 - Sterile Protective Barrier Kit: 2024-07-25
• 10841912106520 - Sterile Protective Barrier Kit: 2024-07-25
• 00841912106691 - Reusable Biopsy Bracket: 2022-06-10 Reusable Biopsy Bracket for Mindray L12-4s, 7L4s, L14-6Ns, L14-6NE & L12-3E Ultrasound Transducers
• 00841912106745 - Biopsy Starter Kit: 2022-06-10 Biopsy Starter Kit for Mindray L12-4s, 7L4s, L14-6Ns, L14-6NE & L12-3E Ultrasound Transducers
• 10841912107107 - Sterile Disposable Endocavity Needle Guide: 2022-04-11 Sterile Disposable Endocavity Needle Guide for Ultrasound Transducers