Localizer Instrument Cover Kit 1080

GUDID 10841912104410

PROTEK MEDICAL PRODUCTS, INC.

Body-surface ultrasound imaging transducer cover

• Primary Device ID: 10841912104410
• NIH Device Record Key: 9d474974-343f-4c9b-bcb7-f3b41d7454f1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Localizer Instrument Cover Kit
• Version Model Number: 1080
• Catalog Number: 1080
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• 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	00841912104413 [Primary]
GS1	10841912104410 [Package]; Contains: 00841912104413; Package: [24 Units]; In Commercial Distribution
GS1	20841912104417 [Package]; Contains: 00841912104413; Package: Box [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K970885

FDA Product Code

• MMP: Cover, Barrier, Protective

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-05-14
• Device Publish Date: 2016-09-16

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