CranioSculpt

Basic Information

• Brand Name: CranioSculpt
• Primary DI: 00813845020368
• Version / Model: C-FLOW10CC
• Catalog Number: C-FLOW10CC
• Company Name: SKELETAL KINETICS LLC
• Labeler DUNS: 140071411
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-10-30
• Public Version: 6
• Public Version Date: 2021-03-22
• Public Version Status: Update
• Public Device Record Key: 4ca1c72d-3b2b-48b1-8303-7bf9921ba2d3
• Distribution End Date: 2021-01-01

Device Description

CranioSculpt Flow Bone Void Filler

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: Yes
• 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
GXP	METHYL METHACRYLATE FOR CRANIOPLASTY	Neurology	882.5300	2

GMDN Terms

Code	Name	Definition	Implantable	Status
17751	Bone matrix implant, synthetic, non-antimicrobial	A bioabsorbable device made of synthetic material intended to be implanted into the body to provide osteoconductive bone-tissue scaffolds, and sometimes osteovascularization, to replace bone lost through trauma, surgery, or pathological conditions (e.g., osteoporosis); it does not include an antimicrobial agent(s). It may be made of ceramics (e.g., tricalcium phosphate or hydroxyapatite), bioactive glasses/minerals/metals (e.g., strontium), or bioabsorbable polymers. It is used to fill cystic defects, repair fractures, and/or extend autogenous bone grafts and is typically provided as cancellous blocks, chips, or granules of varying sizes, or mouldable/fluid materials.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00813845020368	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Total Volume	10	Milliliter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius