Lotus™ Introducer Set LIS-L

GUDID 05391526210116

Lotus™ Introducer Set, Large

CREGANNA UNLIMITED COMPANY

Vascular catheter introduction set, nonimplantable

• Primary Device ID: 05391526210116
• NIH Device Record Key: b84c8676-0417-491f-9bd3-24f7fd6c5f71
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lotus™ Introducer Set
• Version Model Number: H749NTR200
• Catalog Number: LIS-L
• Company DUNS: 985218606
• Company Name: CREGANNA UNLIMITED COMPANY
• 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: false
• 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 Dimensions

• Device Size Text, specify: 0
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• Length: 47.5 Centimeter
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• Length: 30.5 Centimeter
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• Device Size Text, specify: 0
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• Length: 47.5 Centimeter
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• Length: 30.5 Centimeter
• Device Size Text, specify: 0
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• Length: 47.5 Centimeter
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• Device Size Text, specify: 0
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• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 47.5 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 30.5 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 47.5 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 30.5 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 47.5 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 30.5 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 47.5 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 30.5 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 47.5 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 30.5 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 47.5 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 30.5 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 47.5 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 30.5 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 47.5 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 30.5 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 47.5 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 30.5 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 47.5 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 30.5 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 47.5 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 30.5 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	05391526210116 [Primary]

FDA Product Code

• DYB: Introducer, Catheter

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: 2019-06-07
• Device Publish Date: 2016-09-23

On-Brand Devices [Lotus™ Introducer Set]

• 05391526210116: Lotus™ Introducer Set, Large
• 05391526210109: Lotus™ Introducer Set, Small