3CRF V Nav Sensor Holder

GUDID 00841912101948

GE 3CRF V Nav Sensor (Style 2) Holder

PROTEK MEDICAL PRODUCTS, INC.

Ultrasound imaging system tracking holder, reusable

• Primary Device ID: 00841912101948
• NIH Device Record Key: 1f464518-b884-4ec3-9a56-22797a7f51c1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 3CRF V Nav Sensor Holder
• Version Model Number: 6099
• 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: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841912101948 [Direct Marking]
GS1	10841912101945 [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

[00841912101948]

High-level Disinfectant

[00841912101948]

High-level Disinfectant

[00841912101948]

High-level Disinfectant

[00841912101948]

High-level Disinfectant

[00841912101948]

High-level Disinfectant

[00841912101948]

High-level Disinfectant

[00841912101948]

High-level Disinfectant

[00841912101948]

High-level Disinfectant

[00841912101948]

High-level Disinfectant

[00841912101948]

High-level Disinfectant

[00841912101948]

High-level Disinfectant

[00841912101948]

High-level Disinfectant

[00841912101948]

High-level Disinfectant

[00841912101948]

High-level Disinfectant

[00841912101948]

High-level Disinfectant

[00841912101948]

High-level Disinfectant

[00841912101948]

High-level Disinfectant

[00841912101948]

High-level Disinfectant

[00841912101948]

High-level Disinfectant

[00841912101948]

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: 2016-09-16

On-Brand Devices [3CRF V Nav Sensor Holder]

• 00841912101948: GE 3CRF V Nav Sensor (Style 2) Holder
• 00841912101931: GE 3CRF V Nav Sensor Holder