Sublime™ Radial Access Guide Sheath

GUDID 05391525785127

CREAGH MEDICAL LIMITED

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• Primary Device ID: 05391525785127
• NIH Device Record Key: 91a5bb9d-f8ee-4efb-846c-7d665e22edd4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sublime™ Radial Access Guide Sheath
• Version Model Number: SRA-GS35-5F120
• Company DUNS: 985021909
• Company Name: CREAGH MEDICAL LIMITED
• 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
• Length: 120 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 120 Centimeter
• Device Size Text, specify: 0
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• Device Size Text, specify: 0
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• Device Size Text, specify: 0
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• Device Size Text, specify: 0
• Device Size Text, specify: 0
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• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 120 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 120 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
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• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 120 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 120 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
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• Device Size Text, specify: 0
• Device Size Text, specify: 0
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• Device Size Text, specify: 0
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• Device Size Text, specify: 0
• Device Size Text, specify: 0
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• Device Size Text, specify: 0
• Device Size Text, specify: 0
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• Device Size Text, specify: 0
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• Device Size Text, specify: 0
• Device Size Text, specify: 0
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• Device Size Text, specify: 0
• Device Size Text, specify: 0
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• Device Size Text, specify: 0
• Device Size Text, specify: 0
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• Device Size Text, specify: 0
• Device Size Text, specify: 0
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• Device Size Text, specify: 0
• Device Size Text, specify: 0
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• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 120 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
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• Device Size Text, specify: 0
• Device Size Text, specify: 0
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• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 120 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 120 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 120 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 120 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 120 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 120 Centimeter
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	05391525785127 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190644

FDA Product Code

• DYB: Introducer, Catheter

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-12-15
• Device Publish Date: 2020-12-07

On-Brand Devices [Sublime™ Radial Access Guide Sheath]

• 05391525785189: SRA-GS35-6F150
• 05391525785172: SRA-GS18-6F150
• 05391525785165: SRA-GS35-6F120
• 05391525785158: SRA-GS18-6F120
• 05391525785141: SRA-GS35-5F150
• 05391525785134: SRA-GS18-5F150
• 05391525785127: SRA-GS35-5F120
• 05391525785110: SRA-GS18-5F120