Reusable Biopsy Bracket

GUDID 00841912107049

Biospy Bracket for Zonare L10-5 Ultrasound Transducers

PROTEK MEDICAL PRODUCTS, INC.

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• Primary Device ID: 00841912107049
• NIH Device Record Key: 8158dedf-d90a-4710-890c-c7c99b21be91
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Reusable Biopsy Bracket
• Version Model Number: 6296
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841912107049 [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

[00841912107049]

High-level Disinfectant

[00841912107049]

High-level Disinfectant

[00841912107049]

High-level Disinfectant

[00841912107049]

High-level Disinfectant

[00841912107049]

High-level Disinfectant

[00841912107049]

High-level Disinfectant

[00841912107049]

High-level Disinfectant

[00841912107049]

High-level Disinfectant

[00841912107049]

High-level Disinfectant

[00841912107049]

High-level Disinfectant

[00841912107049]

High-level Disinfectant

[00841912107049]

High-level Disinfectant

[00841912107049]

High-level Disinfectant

[00841912107049]

High-level Disinfectant

[00841912107049]

High-level Disinfectant

[00841912107049]

High-level Disinfectant

[00841912107049]

High-level Disinfectant

[00841912107049]

High-level Disinfectant

[00841912107049]

High-level Disinfectant

[00841912107049]

High-level Disinfectant

[00841912107049]

High-level Disinfectant

[00841912107049]

High-level Disinfectant

[00841912107049]

High-level Disinfectant

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-12-27
• Device Publish Date: 2021-12-17

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