IsoTis Mozaik Moldable Morsels

Basic Information

• Brand Name: IsoTis Mozaik Moldable Morsels
• Primary DI: 10889981056063
• Version / Model: MSL150
• Catalog Number: MSL150
• Company Name: ISOTIS ORTHOBIOLOGICS, INC.
• Labeler DUNS: 801089152
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-09-24
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: cf02a623-b93b-45c2-a291-75d7c6810c50

Device Description

IsoTis Mozaik™ Moldable Morsels Mega, 2 X 7.5cc - A resorbable bone void filler made from microfibrillar collagen combined with tricalcium phosphate (TCP) granules and cubes.

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
47967	Bone matrix implant, composite	A sterile bioabsorbable device made of synthetic bone substitute materials (e.g., ceramics such as tricalcium phosphate or hydroxyapatite) combined with bone growth factors (e.g., bovine collagen) implanted into the body to provide osteoconductive bone-tissue scaffolds to replace bone lost through trauma, surgery, or pathological conditions (e.g., osteoporosis). It is used to fill cystic defects, repair fractures, and/or extend autogenous bone grafts. It is typically provided as cancellous blocks, chips, or granules of varying sizes, or mouldable materials.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Secondary	M269MSL1501	HIBCC
Primary	10889981056063	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K091302	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			2x7.5cc

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 10 – 30 Degrees Celsius