CRANIOPLASTIC

Basic Information

• Brand Name: CRANIOPLASTIC
• Primary DI: 10886704015505
• Version / Model: 43-1280
• Catalog Number: 431280
• Company Name: Cerenovus, Inc.
• Labeler DUNS: 607846297
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-09-20
• Public Version: 6
• Public Version Date: 2023-09-15
• Public Version Status: Update
• Public Device Record Key: 57d51ecb-df97-44f4-a980-5582f08ff197
• Distribution End Date: 2022-09-01

Device Description

Codman CRANIOPLASTIC Resinous Material for Repairing Cranial Defects

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
GXP	METHYL METHACRYLATE FOR CRANIOPLASTY	Neurology	882.5300	2

GMDN Terms

Code	Name	Definition	Implantable	Status
16131	Cranial resinous compound	A substance used to reconstitute cranial bone after neurosurgery (i.e., cranioplasty). It typically consists of a self-curing resin [e.g., polymethylmethacrylate (PMMA)] or a two part resinous material made of several compositions. It may be conformed as an inert implant in an appropriate shape (e.g., a plate) needed to repair the defect of the skull, either using an intraoperatively cured solid composition, or a preoperatively fabricated, porous, custom-made, implant. After application, this device cannot be reused.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10886704015505	GS1

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep away from Sunlight
• Type: Special Storage Condition, Specify
• Special Conditions: Flammable
• Type: Handling Environment Temperature
• Temperature Range: High: 25 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: High: 25 Degrees Celsius