CMFlex

GUDID 00860009902008

CMFlex Block for bone graft 38 x 38 x 9 (mm)

Dimension INX Corp

Synthetic bone graft

• Primary Device ID: 00860009902008
• NIH Device Record Key: e43e3362-5237-41ef-8bec-cecf921a1d85
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CMFlex
• Version Model Number: CMFB13
• Company DUNS: 080931808
• Company Name: Dimension INX Corp
• 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

Customer Support Contacts

• Phone: 312-846-1090
• Email: inquiry@dimensioninx.com
• Phone: 312-846-1090
• Email: inquiry@dimensioninx.com
• Phone: 312-846-1090
• Email: inquiry@dimensioninx.com
• Phone: 312-846-1090
• Email: inquiry@dimensioninx.com
• Phone: 312-846-1090
• Email: inquiry@dimensioninx.com
• Phone: 312-846-1090
• Email: inquiry@dimensioninx.com
• Phone: 312-846-1090
• Email: inquiry@dimensioninx.com
• Phone: 312-846-1090
• Email: inquiry@dimensioninx.com
• Phone: 312-846-1090
• Email: inquiry@dimensioninx.com
• Phone: 312-846-1090
• Email: inquiry@dimensioninx.com
• Phone: 312-846-1090
• Email: inquiry@dimensioninx.com

Device Dimensions

• Length: 38 Millimeter
• Width: 38 Millimeter
• Height: 9 Millimeter
• Length: 38 Millimeter
• Width: 38 Millimeter
• Height: 9 Millimeter
• Length: 38 Millimeter
• Width: 38 Millimeter
• Height: 9 Millimeter
• Length: 38 Millimeter
• Width: 38 Millimeter
• Height: 9 Millimeter
• Length: 38 Millimeter
• Width: 38 Millimeter
• Height: 9 Millimeter
• Length: 38 Millimeter
• Width: 38 Millimeter
• Height: 9 Millimeter
• Length: 38 Millimeter
• Width: 38 Millimeter
• Height: 9 Millimeter
• Length: 38 Millimeter
• Width: 38 Millimeter
• Height: 9 Millimeter
• Length: 38 Millimeter
• Width: 38 Millimeter
• Height: 9 Millimeter
• Length: 38 Millimeter
• Width: 38 Millimeter
• Height: 9 Millimeter
• Length: 38 Millimeter
• Width: 38 Millimeter
• Height: 9 Millimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between -30 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860009902008 [Primary]
GS1	10860009902005 [Package]; Package: [10 Units]; In Commercial Distribution
GS1	20860009902002 [Package]; Package: [5 Units]; In Commercial Distribution
GS1	30860009902009 [Package]; Package: [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213260

FDA Product Code

• LYC: Bone Grafting Material, Synthetic

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-09-04
• Device Publish Date: 2023-08-25