GRAFT DELIVERY DEVICE

GUDID 00815634020634

Graft Delivery Device - Molded Tray in Pouch

MICROMEDICS, INC.

Bone graft delivery kit

• Primary Device ID: 00815634020634
• NIH Device Record Key: a69026c0-81ca-4a01-b76b-22b59dad3cf9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GRAFT DELIVERY DEVICE
• Version Model Number: GD-5515
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815634020634 [Primary]
GS1	10815634020631 [Package]; Package: SHELF BOX [5 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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-25

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