PURcrystals™ BioCeramic NanoCrystals

Basic Information

• Brand Name: PURcrystals™ BioCeramic NanoCrystals
• Primary DI: 00816125023929
• Version / Model: PURcrystals-10
• Catalog Number: PURcrystals-10
• Company Name: BERKELEY ADVANCED BIOMATERIALS, LLC
• Labeler DUNS: 081067703
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-19
• Public Version: 1
• Public Version Date: 2022-12-27
• Public Version Status: New
• Public Device Record Key: f3dc6cd0-fb55-471c-989d-dc963b09c002

Device Description

PURcrystals™ BioCeramic Nanocrystals are a mixture with a nominal composition of 60% hydroxyapatite and 40% beta-tri-calcium phosphate. These materials have been the topic of extensive clinical studies for a several decades. PURcrystals™ is safe and has excellent biocompatibility. After it is implanted, the implant resorbs and is later replaced by natural bone. PURcrystals™ is a natural choice for sparing patients the trauma of autograft harvesting. It also provides a safe alternative to human or animal cadaver bone that completely eliminates the potential for disease transmission.

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: Yes
• 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
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	888.3045	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	00816125023929	GS1

Premarket Submissions

Submission Number	Supplement Number
K023703	000