NA

Basic Information

• Brand Name: NA
• Primary DI: 00840085272271
• Version / Model: JABB00025
• Catalog Number: JABB00025
• Company Name: HYHTE HOLDINGS, INC.
• Labeler DUNS: 073029645
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-01-09
• Public Version: 1
• Public Version Date: 2024-01-17
• Public Version Status: New
• Public Device Record Key: b96459d3-1df0-406c-b2bf-c4afe17d6e11

Device Description

ASYN, MOLDABLE BIOACTIVE BONE GRAFT, 2.5 CC

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: Yes
• 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: Yes
• Has Expiration Date: Yes
• Has Donation ID: Yes

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
60504	Vertebral bone filler, bioabsorbable	A sterile substance intended to be used to replace cortical/cancellous bone in a vertebral body to stabilize vertebral compression fractures (VCFs) caused by cancer, osteoporosis, or trauma. The device is typically a sterile powder made of a calcium compound (e.g., calcium phosphate, calcium carbonate, hydroxyapatite), that is mixed with its sterile diluent prior to implantation, and designed to be implanted during a balloon kyphoplasty or vertebroplasty procedure. This device does not contain an antibiotic agent. 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	00840085272271	GS1

Customer Contacts

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