SafeSheath™ FCL-047-08

GUDID 10884450281342

Merit Medical

Vascular catheter introduction set, nonimplantable

• Primary Device ID: 10884450281342
• NIH Device Record Key: 310500e1-83ce-4983-8849-ea5c99b050f7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SafeSheath™
• Version Model Number: 00884450281345
• Catalog Number: FCL-047-08
• Company DUNS: 065673912
• Company Name: Merit Medical
• 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: 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

Device Dimensions

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Device Identifiers

Device Issuing Agency	Device ID
GS1	00884450281345 [Primary]
GS1	10884450281342 [Package]; Contains: 00884450281345; Package: [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K934901

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: 4
• Public Version Date: 2019-06-07
• Device Publish Date: 2017-02-23

On-Brand Devices [SafeSheath™]

• 10884450396077: 00884450396070
• 10884450396060: 00884450396063
• 10884450396046: 00884450396049
• 10884450396039: 00884450396032
• 10884450396022: 00884450396025
• 10884450396015: 00884450396018
• 10884450396008: 00884450396001
• 10884450395995: 00884450395998
• 10884450395988: 00884450395981
• 10884450395971: 00884450395974
• 10884450395964: 00884450395967
• 10884450395957: 00884450395950
• 10884450395940: 00884450395943
• 10884450281496: 00884450281499
• 10884450281489: 00884450281482
• 10884450281472: 00884450281475
• 10884450281465: 00884450281468
• 10884450281458: 00884450281451
• 10884450281441: 00884450281444
• 10884450281397: 00884450281390
• 10884450281366: 00884450281369
• 10884450281359: 00884450281352
• 10884450281342: 00884450281345
• 10884450281335: 00884450281338
• 10884450281328: 00884450281321
• 10884450281311: 00884450281314
• 10884450281304: 00884450281307
• 10884450281298: 00884450281291
• 10884450281120: 00884450281123
• 10884450281113: 00884450281116
• 10884450281106: 00884450281109
• 10884450281373: 10884450281373
• 10884450281199: 10884450281199
• 10884450281090: 10884450281090