BioSphere Flex, Large

Basic Information

• Brand Name: BioSphere Flex, Large
• Primary DI: M958BSF251000
• Version / Model: BSF-25100
• Company Name: SYNERGY BIOMEDICAL, LLC
• Labeler DUNS: 078270195
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-06-01
• Public Version: 1
• Public Version Date: 2021-06-09
• Public Version Status: New
• Public Device Record Key: 29b618e5-ad05-4de4-b12a-f3a42f84c1e6

Device Description

BioSphere Flex, Large

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
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	M958BSF251000	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K173424	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			15cc
Device Size Text, specify			Large
Device Size Text, specify			25mm x 100mm x 6mm

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: – 25 Degrees Celsius