IMPIX ALIF D B15121612

GUDID 03613720193647

IMPIX-ALIF D 16mm at 12°

MEDICREA INTERNATIONAL

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• Primary Device ID: 03613720193647
• NIH Device Record Key: 6e59a663-9c08-4022-876f-504e7d81eb82
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IMPIX ALIF D
• Version Model Number: B15121612
• Catalog Number: B15121612
• Company DUNS: 383228632
• Company Name: MEDICREA INTERNATIONAL
• 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	03613720193647 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K083798

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-08-06
• Device Publish Date: 2015-10-24

On-Brand Devices [IMPIX ALIF D]

• 03613720193678: IMPIX-ALIF D 18mm at 12°
• 03613720193654: IMPIX-ALIF D 18mm at 6°
• 03613720193647: IMPIX-ALIF D 16mm at 12°
• 03613720193630: IMPIX-ALIF D 16mm at 9°
• 03613720193623: IMPIX-ALIF D 16mm at 6°
• 03613720193616: IMPIX-ALIF D 14mm at 12°
• 03613720193609: IMPIX-ALIF D 14mm at 9°
• 03613720193593: IMPIX-ALIF D 14mm at 6°
• 03613720193586: IMPIX-ALIF D 12mm at 12°
• 03613720193579: IMPIX-ALIF D 12mm at 9°
• 03613720193562: IMPIX-ALIF D 12mm at 6°
• 03613720193555: IMPIX-ALIF D 10mm at 12°
• 03613720193548: IMPIX-ALIF D 10mm at 9°
• 03613720193531: IMPIX-ALIF D 10mm at 6°