Non-Sterile Probe Cover Kit 2255

GUDID 10841912104175

PROTEK MEDICAL PRODUCTS, INC.

Cable/lead/sensor/probe cover, sterile

• Primary Device ID: 10841912104175
• NIH Device Record Key: 194ebd3e-c378-4927-b610-a8d76d34b3d8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Non-Sterile Probe Cover Kit
• Version Model Number: 2255
• Catalog Number: 2255
• 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: true
• RX Perscription: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841912104178 [Primary]
GS1	10841912104175 [Package]; Contains: 00841912104178; Package: [50 Units]; In Commercial Distribution

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: 2018-07-06
• Device Publish Date: 2016-09-16

Devices Manufactured by PROTEK MEDICAL PRODUCTS, INC.

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