PullUp Probe Cover Kit 2231

GUDID 10841912100368

PROTEK MEDICAL PRODUCTS, INC.

Cable/lead/sensor/probe cover, sterile

• Primary Device ID: 10841912100368
• NIH Device Record Key: 3270563f-c184-4b21-a52f-c786d01bc841
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PullUp Probe Cover Kit
• Version Model Number: 2231
• Catalog Number: 2231
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841912100361 [Primary]
GS1	10841912100368 [Package]; Contains: 00841912100361; Package: [24 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: true

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

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• 10841912102874: 2231
• 10841912100627: 1096
• 10841912100382: 2233
• 10841912100375: 2233
• 10841912100368: 2231
• 10841912100207: 2099
• 00841912100194: 2099
• 00841912100187: 2097
• 10841912100177: 2097
• 00841912100163: 2097
• 10841912100153: 2096
• 00841912100149: 2095
• 10841912106735: 2048
• 10841912106315: 2044