Reusable Endocavity Needle Guide

GUDID 00841912102662

Stainless Steel Reusable Endocavity Needle Guide for Ultrasonix EC9-5/10, Prosonic EC10R and Samsung Medison EV4-9/10ED & ER4-9/10ED Ultrasound Transducers

PROTEK MEDICAL PRODUCTS, INC.

Nonimplantable needle guide, reusable

• Primary Device ID: 00841912102662
• NIH Device Record Key: 518e6cae-418f-42f4-8fca-26b2ceb4579e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Reusable Endocavity Needle Guide
• Version Model Number: 6456
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• 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	00841912102662 [Direct Marking]
GS1	10841912102669 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K971115

FDA Product Code

• ITX: Transducer, Ultrasonic, Diagnostic

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00841912102662]

Moist Heat or Steam Sterilization

[00841912102662]

Moist Heat or Steam Sterilization

[00841912102662]

Moist Heat or Steam Sterilization

[00841912102662]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2019-12-23
• Device Publish Date: 2016-09-16

On-Brand Devices [Reusable Endocavity Needle Guide]

• 00841912102686: Stainless Steel Reusable Endocavity Needle Guide for Shimadzu UB10R-065U Ultrasound Transducers
• 00841912102679: Stainless Steel Reusable Endocavity Needle Guide for Shimadzu UB10R-065U Ultrasound Transducers
• 00841912102662: Stainless Steel Reusable Endocavity Needle Guide for Ultrasonix EC9-5/10, Prosonic EC10R and Sam