MAR0Fuse

GUDID M896MAR0FUSE10CC1

MAR0FUSE Demineralized Bone Matrix Gel

ARTERIOCYTE MEDICAL SYSTEMS, INC.

Bone matrix implant, human-derived Bone matrix implant, human-derived Bone matrix implant, human-derived Bone matrix implant, human-derived Bone matrix implant, human-derived Bone matrix implant, human-derived Bone matrix implant, human-derived Bone matrix implant, human-derived Bone matrix implant, human-derived Bone matrix implant, human-derived Bone matrix implant, human-derived Bone matrix implant, human-derived Bone matrix implant, human-derived Bone matrix implant, human-derived Bone matrix implant, human-derived Bone matrix implant, human-derived

• Primary Device ID: M896MAR0FUSE10CC1
• NIH Device Record Key: b8adb3fe-3784-4db0-ab42-fe08206df9e5
• Commercial Distribution Discontinuation: 2019-11-12
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: MAR0Fuse
• Version Model Number: MAR0Fuse10cc
• Company DUNS: 809012870
• Company Name: ARTERIOCYTE MEDICAL SYSTEMS, 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: false
• 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

Customer Support Contacts

• Phone: 8666602674
• Email: xxx@xx.xx
• Phone: 8666602674
• Email: xxx@xx.xx
• Phone: 8666602674
• Email: xxx@xx.xx
• Phone: 8666602674
• Email: xxx@xx.xx
• Phone: 8666602674
• Email: xxx@xx.xx
• Phone: 8666602674
• Email: xxx@xx.xx
• Phone: 8666602674
• Email: xxx@xx.xx
• Phone: 8666602674
• Email: xxx@xx.xx
• Phone: 8666602674
• Email: xxx@xx.xx
• Phone: 8666602674
• Email: xxx@xx.xx
• Phone: 8666602674
• Email: xxx@xx.xx
• Phone: 8666602674
• Email: xxx@xx.xx
• Phone: 8666602674
• Email: xxx@xx.xx
• Phone: 8666602674
• Email: xxx@xx.xx
• Phone: 8666602674
• Email: xxx@xx.xx
• Phone: 8666602674
• Email: xxx@xx.xx

Device Dimensions

• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M896MAR0FUSE10CC1 [Primary]

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: 2019-11-13
• Device Publish Date: 2015-11-13

On-Brand Devices [MAR0Fuse]

• M896MAR0FUSE5CC1: MAR0Fuse Demineralized Bone Matrix Gel
• M896MAR0FUSE1CC1: MAR0Fuse Demineralized Bone Matrix Gel
• M896MAR0FUSE10CC1: MAR0FUSE Demineralized Bone Matrix Gel