Reusable 3D Sensor Holder SSIP02889

GUDID 00841912104628

Supersonic Imagine SL 10-2 Sensor Holder

PROTEK MEDICAL PRODUCTS, INC.

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• Primary Device ID: 00841912104628
• NIH Device Record Key: 81eef34b-9fe1-45f3-a8eb-16fc629d6c3d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Reusable 3D Sensor Holder
• Version Model Number: 6255
• Catalog Number: SSIP02889
• 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: false
• Expiration Date: false
• 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	00841912104628 [Direct Marking]
GS1	10841912104625 [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

[00841912104628]

High-level Disinfectant

[00841912104628]

High-level Disinfectant

[00841912104628]

High-level Disinfectant

[00841912104628]

High-level Disinfectant

[00841912104628]

High-level Disinfectant

[00841912104628]

High-level Disinfectant

[00841912104628]

High-level Disinfectant

[00841912104628]

High-level Disinfectant

[00841912104628]

High-level Disinfectant

[00841912104628]

High-level Disinfectant

[00841912104628]

High-level Disinfectant

[00841912104628]

High-level Disinfectant

[00841912104628]

High-level Disinfectant

[00841912104628]

High-level Disinfectant

[00841912104628]

High-level Disinfectant

[00841912104628]

High-level Disinfectant

[00841912104628]

High-level Disinfectant

[00841912104628]

High-level Disinfectant

[00841912104628]

High-level Disinfectant

[00841912104628]

High-level Disinfectant

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2019-12-23
• Device Publish Date: 2016-10-25

On-Brand Devices [Reusable 3D Sensor Holder]

• 00841912104666: Supersonic Imagine SEV12-3 Sensor Holder
• 00841912104642: Supersonic Imagine SE12-3 Sensor Holder
• 00841912104628: Supersonic Imagine SL 10-2 Sensor Holder
• 00841912104611: Supersonic Imagine XC6-1 Sensor Holder