IMPIX DLIF B16104009

GUDID 03613720196044

IMPIX-DLIF LUMBAR CAGE 40mm x 9mm - 0°

MEDICREA INTERNATIONAL

Polymeric spinal interbody fusion cage

• Primary Device ID: 03613720196044
• NIH Device Record Key: 3ffcf86e-3eb5-47f3-947a-9fe15dc1cced
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IMPIX DLIF
• Version Model Number: B16104009
• Catalog Number: B16104009
• 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	03613720196044 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100544

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 DLIF]

• 03613720196730: IMPIX-DLIF LUMBAR CAGE 60mm x 17mm - 6°
• 03613720196723: IMPIX-DLIF LUMBAR CAGE 60mm x 15mm - 6°
• 03613720196716: IMPIX-DLIF LUMBAR CAGE 60mm x 13mm - 6°
• 03613720196709: IMPIX-DLIF LUMBAR CAGE 60mm x 11mm - 6°
• 03613720196693: IMPIX-DLIF LUMBAR CAGE 60mm x 9mm - 6°
• 03613720196686: IMPIX-DLIF LUMBAR CAGE 55mm x 17mm - 6°
• 03613720196679: IMPIX-DLIF LUMBAR CAGE 55mm x 15mm - 6°
• 03613720196662: IMPIX-DLIF LUMBAR CAGE 55mm x 13mm - 6°
• 03613720196655: IMPIX-DLIF LUMBAR CAGE 55mm x 11mm - 6°
• 03613720196648: IMPIX-DLIF LUMBAR CAGE 55mm x 9mm - 6°
• 03613720196631: IMPIX-DLIF LUMBAR CAGE 50mm x 17mm - 6°
• 03613720196624: IMPIX-DLIF LUMBAR CAGE 50mm x 15mm - 6°
• 03613720196617: IMPIX-DLIF LUMBAR CAGE 50mm x 13mm - 6°
• 03613720196600: IMPIX-DLIF LUMBAR CAGE 50mm x 11mm - 6°
• 03613720196594: IMPIX-DLIF LUMBAR CAGE 50mm x 9mm - 6°
• 03613720196587: IMPIX-DLIFLUMBAR CAGE 45mm x 17mm - 6°
• 03613720196570: IMPIX-DLIFLUMBAR CAGE 45mm x 15mm - 6°
• 03613720196563: IMPIX-DLIFLUMBAR CAGE 45mm x 13mm - 6°
• 03613720196556: IMPIX-DLIFLUMBAR CAGE 45mm x 11mm - 6°
• 03613720196549: IMPIX-DLIFLUMBAR CAGE 45mm x 9mm - 6°
• 03613720196532: IMPIX-DLIF LUMBAR CAGE 40mm x 17mm - 6°
• 03613720196525: IMPIX-DLIF LUMBAR CAGE 40mm x 15mm - 6°
• 03613720196518: IMPIX-DLIF LUMBAR CAGE 40mm x 13mm - 6°
• 03613720196501: IMPIX-DLIF LUMBAR CAGE 40mm x 11mm - 6°
• 03613720196495: IMPIX-DLIF LUMBAR CAGE 40mm x 9mm - 6°
• 03613720196280: IMPIX-DLIF LUMBAR CAGE 60mm x 17mm - 0°
• 03613720196273: IMPIX-DLIF LUMBAR CAGE 60mm x 15mm - 0°
• 03613720196266: IMPIX-DLIF LUMBAR CAGE 60mm x 13mm - 0°
• 03613720196259: IMPIX-DLIF LUMBAR CAGE 60mm x 11mm - 0°
• 03613720196242: IMPIX-DLIF LUMBAR CAGE 60mm x 9mm - 0°
• 03613720196235: IMPIX-DLIF LUMBAR CAGE 55mm x 17mm - 0°
• 03613720196228: IMPIX-DLIF LUMBAR CAGE 55mm x 15mm - 0°
• 03613720196211: IMPIX-DLIF LUMBAR CAGE 55mm x 13mm - 0°
• 03613720196204: IMPIX-DLIF LUMBAR CAGE 55mm x 11mm - 0°
• 03613720196198: IMPIX-DLIF LUMBAR CAGE 55mm x 9mm - 0°
• 03613720196181: IMPIX-DLIF LUMBAR CAGE 50mm x 17mm - 0°
• 03613720196174: IMPIX-DLIF LUMBAR CAGE 50mm x 15mm - 0°
• 03613720196167: IMPIX-DLIF LUMBAR CAGE 50mm x 13mm - 0°
• 03613720196150: IMPIX-DLIF LUMBAR CAGE 50mm x 11mm - 0°
• 03613720196143: IMPIX-DLIF LUMBAR CAGE 50mm x 9mm - 0°
• 03613720196136: IMPIX-DLIF LUMBAR CAGE 45mm x 17mm - 0°
• 03613720196129: IMPIX-DLIF LUMBAR CAGE 45mm x 15mm - 0°
• 03613720196112: IMPIX-DLIF LUMBAR CAGE 45mm x 13mm - 0°
• 03613720196105: IMPIX-DLIF LUMBAR CAGE 45mm x 11mm - 0°
• 03613720196099: IMPIX-DLIF LUMBAR CAGE 45mm x 9mm - 0°
• 03613720196082: IMPIX-DLIF LUMBAR CAGE 40mm x 17mm - 0°
• 03613720196075: IMPIX-DLIF LUMBAR CAGE 40mm x 15mm - 0°
• 03613720196068: IMPIX-DLIF LUMBAR CAGE 40mm x 13mm - 0°
• 03613720196051: IMPIX-DLIF LUMBAR CAGE 40mm x 11mm - 0°
• 03613720196044: IMPIX-DLIF LUMBAR CAGE 40mm x 9mm - 0°