OsteoIN Demineralized Bone Matrix 2.5cc

GUDID 00849777006439

ONE (1) PACKAGE - CONTAINING 2.5cc

BACTERIN INTERNATIONAL, INC.

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• Primary Device ID: 00849777006439
• NIH Device Record Key: 4316ff0f-2dc6-4823-b715-04752f816a1b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OsteoIN Demineralized Bone Matrix 2.5cc
• Version Model Number: OI025
• Company DUNS: 829387302
• Company Name: BACTERIN INTERNATIONAL, 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: true
• Device Kit: false
• Device Combination Product: true
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: true
• 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	00849777006439 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130498

FDA Product Code

• MQV: Filler, Bone Void, Calcium Compound

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: 2016-10-18

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