IMPIX-L MS4124258

GUDID 03613720209324

IMPIX-L LUMBAR CAGE 14mm x 25mm - 8°

MEDICREA INTERNATIONAL

Polymeric spinal interbody fusion cage

• Primary Device ID: 03613720209324
• NIH Device Record Key: 02bfa55c-f129-4b19-aea8-eccd4528bb96
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IMPIX-L
• Version Model Number: MS4124258
• Catalog Number: MS4124258
• 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	03613720209324 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K072226

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: 2020-08-07
• Device Publish Date: 2015-10-23

On-Brand Devices [IMPIX-L]

• 03613720225270: IMPIX-L HOLDER
• 03613720225300: LARGE CURETTE
• 03613720225256: CUTTER FOR IMPIX-L 14mm
• 03613720225249: CUTTER FOR IMPIX-L 13mm
• 03613720225232: CUTTER FOR IMPIX-L 12mm
• 03613720225225: CUTTER FOR IMPIX-L 11mm
• 03613720225218: CUTTER FOR IMPIX-L 10mm
• 03613720225201: CUTTER FOR IMPIX-L 9mm
• 03613720225195: CUTTER FOR IMPIX-L 8mm
• 03613720225188: REAMER Ø 14mm
• 03613720225171: REAMER Ø 13mm
• 03613720225164: REAMER Ø 12mm
• 03613720225157: REAMER Ø 11mm
• 03613720225140: REAMER Ø 10mm
• 03613720225133: REAMER Ø 9mm
• 03613720225126: REAMER Ø 8mm
• 03613720240389: IMPIX-L LUMBAR CAGE 10mm x 20mm - 0°
• 03613720235316: IMPIX-L LUMBAR CAGE 50 MM x 20 MM - 0°
• 03613720235255: IMPIX-L LUMBAR CAGE 40 MM x 20 MM - 0°
• 03613720235194: IMPIX-L LUMBAR CAGE 30 MM x 20 MM - 0°
• 03613720235132: IMPIX-L LUMBAR CAGE 20 MM x 20 MM - 0°
• 03613720209386: IMPIX-L LUMBAR CAGE 9mm x 25mm - 4°
• 03613720209379: IMPIX-L LUMBAR CAGE 9mm x 25mm - 0°
• 03613720209362: IMPIX-L LUMBAR CAGE 9mm x 20mm - 4°
• 03613720209355: IMPIX-L LUMBAR CAGE 9mm x 20mm - 0°
• 03613720209348: IMPIX-L LUMBAR CAGE 8mm x 25mm - 0°
• 03613720209331: IMPIX-L LUMBAR CAGE 8mm x 20mm - 0°
• 03613720209324: IMPIX-L LUMBAR CAGE 14mm x 25mm - 8°
• 03613720209317: IMPIX-L LUMBAR CAGE 14mm x 25mm - 4°
• 03613720209294: IMPIX-L LUMBAR CAGE 14mm x 25mm - 0°
• 03613720209287: IMPIX-L LUMBAR CAGE 14mm x 20mm - 8°
• 03613720209270: IMPIX-L LUMBAR CAGE 14mm x 20mm - 4°
• 03613720209256: IMPIX-L LUMBAR CAGE 14mm x 20mm - 0°
• 03613720209249: IMPIX-L LUMBAR CAGE 13mm x 25mm - 8°
• 03613720209232: IMPIX-L LUMBAR CAGE 13mm x 25mm - 4°
• 03613720209218: IMPIX-L LUMBAR CAGE 13mm x 25mm - 0°
• 03613720209201: IMPIX-L LUMBAR CAGE 13mm x 20mm - 8°
• 03613720209195: IMPIX-L LUMBAR CAGE 13mm x 20mm - 4°
• 03613720209171: IMPIX-L LUMBAR CAGE 13mm x 20mm - 0°
• 03613720209164: IMPIX-L LUMBAR CAGE 12mm x 25mm - 8°
• 03613720209157: IMPIX-L LUMBAR CAGE 12mm x 25mm - 4°
• 03613720209133: IMPIX-L LUMBAR CAGE 12mm x 25mm - 0°
• 03613720209126: IMPIX-L LUMBAR CAGE 12mm x 20mm - 8°
• 03613720209119: IMPIX-L LUMBAR CAGE 12mm x 20mm - 4°
• 03613720209096: IMPIX-L LUMBAR CAGE 12mm x 20mm - 0°
• 03613720209089: IMPIX-L LUMBAR CAGE 11mm x 25mm - 8°
• 03613720209072: IMPIX-L LUMBAR CAGE 11mm x 25mm - 4°
• 03613720209065: IMPIX-L LUMBAR CAGE 11mm x 25mm - 0°
• 03613720209058: IMPIX-L LUMBAR CAGE 11mm x 20mm - 8°
• 03613720209041: IMPIX-L LUMBAR CAGE 11mm x 20mm - 4°