CMFlex

Basic Information

• Brand Name: CMFlex
• Primary DI: 00860009902008
• Version / Model: CMFB13
• Company Name: Dimension INX Corp
• Labeler DUNS: 080931808
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-08-25
• Public Version: 1
• Public Version Date: 2023-09-04
• Public Version Status: New
• Public Device Record Key: e43e3362-5237-41ef-8bec-cecf921a1d85

Device Description

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

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LYC	Bone Grafting Material, Synthetic	Dental	872.3930	2

GMDN Terms

Code	Name	Definition	Implantable	Status
16966	Synthetic bone graft	An artificial bone substitute used for structural bone replacement typically when bone is lost due to disease (e.g., osteoporosis) or injury. It consists mainly of porous and mesh ceramic materials that provide a framework for bone growth, or harvested sea coral that serves as an additive, extender, or provides a framework for bone growth. This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860009902008	GS1
Package	10860009902005	GS1		10	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K213260	000

Device Sizes

Type	Value	Unit	Text
Length	38	Millimeter
Width	38	Millimeter
Height	9	Millimeter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -30 – 40 Degrees Celsius