Practical Navigation 6005

GUDID 00850003355887

Guide Tube Drape Assembly, Tapered, PU Window, 100x78.5cm

EXACT MEDICAL MANUFACTURING, INC.

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• Primary Device ID: 00850003355887
• NIH Device Record Key: 55f47d36-d2d3-47ee-94a1-2a376a93faf1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Practical Navigation
• Version Model Number: 6005
• Catalog Number: 6005
• Company DUNS: 014464314
• Company Name: EXACT MEDICAL MANUFACTURING, INC.
• Device Count: 1
• DM Exempt: true
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850003355887 [Primary]
GS1	00850033380682 [Package]; Package: inner case [10 Units]; In Commercial Distribution
GS1	00850033380699 [Package]; Contains: 00850033380682; Package: case [2 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101689

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: 2021-10-26
• Device Publish Date: 2019-10-30

On-Brand Devices [Practical Navigation]

• 00850003355894: Guide Tube Drape Assembly, Tapered, PU Window, 100x78.5cm
• 00850003355887: Guide Tube Drape Assembly, Tapered, PU Window, 100x78.5cm