Reusable Single-Angle Biopsy Bracket

GUDID 00841912104581

PROTEK MEDICAL PRODUCTS, INC.

Ultrasound imaging system tracking holder, reusable Ultrasound imaging system tracking holder, reusable Ultrasound imaging system tracking holder, reusable Ultrasound imaging system tracking holder, reusable Ultrasound imaging system tracking holder, reusable Ultrasound imaging system tracking holder, reusable Ultrasound imaging system tracking holder, reusable Ultrasound imaging system tracking holder, reusable Ultrasound imaging system tracking holder, reusable Ultrasound imaging system tracking holder, reusable Ultrasound imaging system tracking holder, reusable Ultrasound imaging system tracking holder, reusable Ultrasound imaging system tracking holder, reusable Ultrasound imaging system tracking holder, reusable Ultrasound imaging system tracking positioner, reusable Ultrasound imaging system tracking positioner, reusable Ultrasound imaging system tracking positioner, reusable Ultrasound imaging system tracking positioner, reusable Ultrasound imaging system tracking positioner, reusable Ultrasound imaging system tracking positioner, reusable

• Primary Device ID: 00841912104581
• NIH Device Record Key: b139c814-93bb-4d0a-9db8-8921b823643d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Reusable Single-Angle Biopsy Bracket
• Version Model Number: 6487
• 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	00841912104581 [Direct Marking]
GS1	10841912104588 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K973958

FDA Product Code

• ITX: Transducer, Ultrasonic, Diagnostic

Sterilization

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

[00841912104581]

Moist Heat or Steam Sterilization

[00841912104581]

Moist Heat or Steam Sterilization

[00841912104581]

Moist Heat or Steam Sterilization

[00841912104581]

Moist Heat or Steam Sterilization

[00841912104581]

Moist Heat or Steam Sterilization

[00841912104581]

Moist Heat or Steam Sterilization

[00841912104581]

Moist Heat or Steam Sterilization

[00841912104581]

Moist Heat or Steam Sterilization

[00841912104581]

Moist Heat or Steam Sterilization

[00841912104581]

Moist Heat or Steam Sterilization

[00841912104581]

Moist Heat or Steam Sterilization

[00841912104581]

Moist Heat or Steam Sterilization

[00841912104581]

Moist Heat or Steam Sterilization

[00841912104581]

Moist Heat or Steam Sterilization

[00841912104581]

Moist Heat or Steam Sterilization

[00841912104581]

Moist Heat or Steam Sterilization

[00841912104581]

Moist Heat or Steam Sterilization

[00841912104581]

Moist Heat or Steam Sterilization

[00841912104581]

Moist Heat or Steam Sterilization

[00841912104581]

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: 2016-09-28

Devices Manufactured by PROTEK MEDICAL PRODUCTS, INC.

• 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
• 10841912107084 - Sterile Single-Use Probe Cover Kit: 2022-03-21
• 10841912107091 - Sterile Single-Use Surgical Probe Cover Kit: 2022-03-21
• 00841912107049 - Reusable Biopsy Bracket: 2021-12-27 Biospy Bracket for Zonare L10-5 Ultrasound Transducers
• 10841912107053 - General Purpose Probe Cover: 2021-12-27
• 00841912107070 - Biopsy Starter Kit: 2021-12-27 Biopsy Starter Kit for Zonare L10-5 Ultrasound Transducers