CRANIOS Reinforced

Basic Information

• Brand Name: CRANIOS Reinforced
• Primary DI: 10887587058634
• Version / Model: 615.03.01S
• Catalog Number: 6150301S
• Company Name: Synthes GmbH
• Labeler DUNS: 486711679
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-09-14
• Public Version: 5
• Public Version Date: 2022-04-25
• Public Version Status: Update
• Public Device Record Key: 854b56af-e4fd-4368-8199-c1e6c7defda5

Device Description

CRANIOS REINFORCED FAST SET PUTTY 3CC-STERILE

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
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
Secondary	H9806150301S0	HIBCC
Primary	10887587058634	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K102018	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 5 – 25 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: .
• Type: Handling Environment Temperature
• Temperature Range: High: 43 Degrees Celsius