RetroFit XT Multi Gauge Needle Guide Kit 5601

GUDID 10841912104403

PROTEK MEDICAL PRODUCTS, INC.

Cable/lead/sensor/probe cover, sterile

• Primary Device ID: 10841912104403
• NIH Device Record Key: 027a5fcf-d12f-42f1-b26d-2430b44f7578
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RetroFit XT Multi Gauge Needle Guide Kit
• Version Model Number: 5601
• Catalog Number: 5601
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841912104406 [Primary]
GS1	10841912104403 [Package]; Contains: 00841912104406; 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: 5
• Public Version Date: 2019-10-07
• Device Publish Date: 2016-09-16

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