Reusable Multi Angle Biopsy Bracket

GUDID 00841912106769

PROTEK MEDICAL PRODUCTS, INC.

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• Primary Device ID: 00841912106769
• NIH Device Record Key: ba619c96-075a-4910-bfae-8b32929260a1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Reusable Multi Angle Biopsy Bracket
• Version Model Number: 6196
• 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	00841912106769 [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

[00841912106769]

High-level Disinfectant

[00841912106769]

High-level Disinfectant

[00841912106769]

High-level Disinfectant

[00841912106769]

High-level Disinfectant

[00841912106769]

High-level Disinfectant

[00841912106769]

High-level Disinfectant

[00841912106769]

High-level Disinfectant

[00841912106769]

High-level Disinfectant

[00841912106769]

High-level Disinfectant

[00841912106769]

High-level Disinfectant

[00841912106769]

High-level Disinfectant

[00841912106769]

High-level Disinfectant

[00841912106769]

High-level Disinfectant

[00841912106769]

High-level Disinfectant

[00841912106769]

High-level Disinfectant

[00841912106769]

High-level Disinfectant

[00841912106769]

High-level Disinfectant

[00841912106769]

High-level Disinfectant

[00841912106769]

High-level Disinfectant

[00841912106769]

High-level Disinfectant

[00841912106769]

High-level Disinfectant

[00841912106769]

High-level Disinfectant

[00841912106769]

High-level Disinfectant

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-07-15
• Device Publish Date: 2021-07-07

On-Brand Devices [Reusable Multi Angle Biopsy Bracket]

• 00841912103034: Multi Angle Bracket for GE 3S/M3S Ultrasound Transducers
• 00841912106769: 6196