OsteoExpress

GUDID 90815634020903

Graft Delivery Device, 15 cc, Bulk, Non Sterile, Vented. Quantity is Maximum 25 as customer orders

MICROMEDICS, INC.

Bone graft delivery kit

• Primary Device ID: 90815634020903
• NIH Device Record Key: 3f64e268-c0d5-4fe8-ae20-0608e7ad27bf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OsteoExpress
• Version Model Number: GDNS-5215
• 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: false
• 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	90815634020903 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151543

FDA Product Code

• FMF: Syringe, Piston

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[90815634020903]

Ethylene Oxide

[90815634020903]

Ethylene Oxide

[90815634020903]

Ethylene Oxide

[90815634020903]

Ethylene Oxide

[90815634020903]

Ethylene Oxide

[90815634020903]

Ethylene Oxide

[90815634020903]

Ethylene Oxide

[90815634020903]

Ethylene Oxide

[90815634020903]

Ethylene Oxide

[90815634020903]

Ethylene Oxide

[90815634020903]

Ethylene Oxide

[90815634020903]

Ethylene Oxide

[90815634020903]

Ethylene Oxide

[90815634020903]

Ethylene Oxide

[90815634020903]

Ethylene Oxide

[90815634020903]

Ethylene Oxide

[90815634020903]

Ethylene Oxide

[90815634020903]

Ethylene Oxide

[90815634020903]

Ethylene Oxide

[90815634020903]

Ethylene Oxide

[90815634020903]

Ethylene Oxide

[90815634020903]

Ethylene Oxide

[90815634020903]

Ethylene Oxide

[90815634020903]

Ethylene Oxide

[90815634020903]

Ethylene Oxide

[90815634020903]

Ethylene Oxide

[90815634020903]

Ethylene Oxide

[90815634020903]

Ethylene Oxide

[90815634020903]

Ethylene Oxide

[90815634020903]

Ethylene Oxide

[90815634020903]

Ethylene Oxide

[90815634020903]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-03-29
• Device Publish Date: 2019-03-21

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