Probe Covers D101713-001

GUDID 10841912105509

PROTEK MEDICAL PRODUCTS, INC.

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• Primary Device ID: 10841912105509
• NIH Device Record Key: 5b282732-ed3e-41c9-8886-95f067e4f890
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Probe Covers
• Version Model Number: 2254
• Catalog Number: D101713-001
• Company DUNS: 965417181
• Company Name: PROTEK MEDICAL PRODUCTS, INC.
• Device Count: 100
• 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: false
• 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	00841912105502 [Unit of Use]
GS1	10841912105509 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K970893

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: 3
• Public Version Date: 2021-01-20
• Device Publish Date: 2018-04-13

Devices Manufactured by PROTEK MEDICAL PRODUCTS, INC.

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