IMPIX TLIF B15130609

GUDID 03613720193739

LUMBAR CAGE IMPIX-TLIF 9mm - 6°

MEDICREA INTERNATIONAL

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• Primary Device ID: 03613720193739
• NIH Device Record Key: a2da618e-f9a7-434b-ab10-cba4ea3f0120
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IMPIX TLIF
• Version Model Number: B15130609
• Catalog Number: B15130609
• 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: true
• 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	03613720193739 [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: 6
• Public Version Date: 2020-08-07
• Device Publish Date: 2015-10-23

On-Brand Devices [IMPIX TLIF]

• 03613720245681: IMPIX-TLIF LUMBAR CAGE 7mm - 6°
• 03613720245674: LUMBAR CAGE IMPIX-TLIF 9mm - 6°
• 03613720193814: LUMBAR CAGE IMPIX-TLIF 17mm - 6°
• 03613720193807: LUMBAR CAGE IMPIX-TLIF 15mm - 6°
• 03613720193791: LUMBAR CAGE IMPIX-TLIF 15mm - 6°
• 03613720193784: LUMBAR CAGE IMPIX-TLIF 13mm - 6°
• 03613720193777: LUMBAR CAGE IMPIX-TLIF 13mm - 6°
• 03613720193760: LUMBAR CAGE IMPIX-TLIF 11mm - 6°
• 03613720193753: LUMBAR CAGE IMPIX-TLIF 11mm - 6°
• 03613720193739: LUMBAR CAGE IMPIX-TLIF 9mm - 6°
• 03613720193715: IMPIX-TLIF LUMBAR CAGE 7mm at 6°