SafeSheath CSG FCL-083-02

GUDID 10884450162054

Merit Medical

Vascular catheter introduction set, nonimplantable

• Primary Device ID: 10884450162054
• NIH Device Record Key: e8e3f1a6-235e-4b5d-8d7e-b0abbcb5ec44
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SafeSheath CSG
• Version Model Number: 00884450162057
• Catalog Number: FCL-083-02
• 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: false
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00884450162057 [Primary]
GS1	10884450162054 [Package]; Contains: 00884450162057; Package: [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120158

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: 2017-02-15

On-Brand Devices [SafeSheath CSG]

• 10884450162108: 00884450162101
• 10884450162061: 00884450162064
• 10884450162054: 00884450162057
• 10884450162047: 00884450162040
• 10884450162030: 00884450162033
• 10884450162009: 00884450162002
• 10884450161996: 00884450161999
• 10884450161989: 00884450161982
• 10884450161972: 00884450161975
• 10884450161958: 00884450161951
• 10884450161941: 00884450161944