Graft Delivery, DePuy Synthes

GUDID 20815634020621

Graft Delivery, DePuy Synthes

MICROMEDICS, INC.

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• Primary Device ID: 20815634020621
• NIH Device Record Key: 174bf360-cfc9-4071-8833-608c2a34262c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Graft Delivery, DePuy Synthes
• Version Model Number: 03-950-001S
• 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: 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 Identifiers

Device Issuing Agency	Device ID
GS1	00815634020627 [Primary]
GS1	10815634020624 [Package]; Contains: 00815634020627; Package: Shelf Box [5 Units]; In Commercial Distribution
GS1	20815634020621 [Package]; Contains: 10815634020624; Package: Ship Box [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173385

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: 2018-07-16
• Device Publish Date: 2018-06-15

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