Sterile Probe Cover Kit with PullUp/pull off extension 1031

GUDID 00841912105663

PROTEK MEDICAL PRODUCTS, INC.

Cable/lead/sensor/probe cover, sterile

• Primary Device ID: 00841912105663
• NIH Device Record Key: 4846e1e6-93b7-45aa-b507-87aff859c004
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sterile Probe Cover Kit with PullUp/pull off extension
• Version Model Number: 1031
• Catalog Number: 1031
• 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	00841912105663 [Previous]
GS1	00841912105885 [Primary]
GS1	10841912105882 [Package]; Contains: 00841912105885; Package: [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K970889

FDA Product Code

• KKX: Drape, Surgical

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-12-17
• Device Publish Date: 2018-11-16

Devices Manufactured by PROTEK MEDICAL PRODUCTS, INC.

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