Medtronic Resilant

GUDID 10815634021140

Syringe Graft Delivery with Integrated Stylet

MICROMEDICS, INC.

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• Primary Device ID: 10815634021140
• NIH Device Record Key: da2a539e-4a75-4caf-b207-b2797b99abe9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Medtronic Resilant
• Version Model Number: 779101
• Company DUNS: 066839630
• Company Name: MICROMEDICS, INC.
• 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: false
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00815634021143 [Primary]
GS1	10815634021140 [Package]; Contains: 00815634021143; Package: Inner Pack [1 Units]; In Commercial Distribution
GS1	20815634021147 [Package]; Package: Case [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151543

FDA Product Code

• FMF: Syringe, Piston

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: 2021-09-01
• Device Publish Date: 2021-08-24

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