Rolled Probe Cover and Rubber Bands VPC0108NS

GUDID 20841912100891

PROTEK MEDICAL PRODUCTS, INC.

Body-orifice ultrasound imaging transducer cover, basic, non-sterile

• Primary Device ID: 20841912100891
• NIH Device Record Key: 6807bf58-9148-4244-83ff-1d9e2c7371b9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rolled Probe Cover and Rubber Bands
• Version Model Number: 3248
• Catalog Number: VPC0108NS
• Company DUNS: 965417181
• Company Name: PROTEK MEDICAL PRODUCTS, INC.
• Device Count: 50
• 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: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841912100897 [Unit of Use]
GS1	20841912100891 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K970891

FDA Product Code

• KKX: Drape, Surgical

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-10-25

Devices Manufactured by PROTEK MEDICAL PRODUCTS, INC.

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