Prelude® Short Sheath PSS-6F-4MT

GUDID 20884450015319

Merit Medical Systems, Inc.

Vascular catheter introduction set, nonimplantable

• Primary Device ID: 20884450015319
• NIH Device Record Key: 6328ecf8-e2ba-4074-9858-fd3d541b2743
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Prelude® Short Sheath
• Version Model Number: 10884450015312
• Catalog Number: PSS-6F-4MT
• Company DUNS: 184763290
• Company Name: Merit Medical Systems, Inc.
• Device Count: 5
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• 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: false
• OTC Over-The-Counter: false

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Device Identifiers

Device Issuing Agency	Device ID
GS1	00884450015315 [Unit of Use]
GS1	10884450015312 [Primary]
GS1	20884450015319 [Package]; Contains: 10884450015312; Package: [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082063

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: 5
• Public Version Date: 2019-06-07
• Device Publish Date: 2016-09-22

On-Brand Devices [Prelude® Short Sheath]

• 20884450123847: 10884450123840
• 20884450123786: 10884450123789
• 20884450123779: 10884450123772
• 20884450015418: 10884450015411
• 20884450015401: 10884450015404
• 20884450015395: 10884450015398
• 20884450015388: 10884450015381
• 20884450015371: 10884450015374
• 20884450015364: 10884450015367
• 20884450015357: 10884450015350
• 20884450015340: 10884450015343
• 20884450015333: 10884450015336
• 20884450015326: 10884450015329
• 20884450015319: 10884450015312
• 20884450015302: 10884450015305