Integra OS®

Basic Information

• Brand Name: Integra OS®
• Primary DI: 10381780071143
• Version / Model: IOSMM015
• Catalog Number: IOSMM015
• Company Name: Integra Lifesciences Corporation
• Labeler DUNS: 083171244
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-09-22
• Public Version: 6
• Public Version Date: 2023-08-22
• Public Version Status: Update
• Public Device Record Key: 885a6442-8e02-43ba-a86b-9669214cb707
• Distribution End Date: 2023-08-15

Device Description

The Integra OS Osteoconductive Scaffold - Moldable Morsels are a resorbable bone void filler made from a porous highly purified microfibrillar collagen combined with high purity tricalcium phosphate (TCP) granules and cubes. The implant is designed to facilitate the repair of bony defects. In the dry state, the matrix has a three dimensional trabecular network of pores that resembles the pore structure of human cancellous bone. It quickly imbibes fluids, making it easy to combine with bone marrow aspirate.

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
Primary	10381780071143	GS1
Secondary	M269IOSMM0151	HIBCC

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			1.5cc

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store at room temperature. Avoid excessive heat or humidy. Do not refrigerate.
• Type: Storage Environment Temperature
• Temperature Range: 10 – 30 Degrees Celsius