IsoTis Mozaik Strip CCM10210

GUDID M386CCM102101

IsoTis Mozaik™ Strip, 10cc - a resorbable bone void filler made from a bovine collagen matrix that has tricalcium phosphate (TCP) granules dispersed t

ISOTIS ORTHOBIOLOGICS, INC.

Bone matrix implant, composite
Primary Device IDM386CCM102101
NIH Device Record Key262971a5-7199-4758-a063-0beabcc01c07
Commercial Distribution StatusIn Commercial Distribution
Brand NameIsoTis Mozaik Strip
Version Model NumberCCM10210
Catalog NumberCCM10210
Company DUNS801089152
Company NameISOTIS ORTHOBIOLOGICS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)550-7155
EmailIrvine.customerservice@seaspin
Phone+1(800)550-7155
EmailIrvine.customerservice@seaspin
Phone+1(800)550-7155
EmailIrvine.customerservice@seaspine.com
Phone+1(800)550-7155
EmailIrvine.customerservice@seaspine.com
Phone+1(800)550-7155
EmailIrvine.customerservice@seaspine.com
Phone+1(800)550-7155
EmailIrvine.customerservice@seaspine.com
Phone+1(800)550-7155
EmailIrvine.customerservice@seaspine.com
Phone+1(800)550-7155
EmailIrvine.customerservice@seaspine.com
Phone+1(800)550-7155
EmailIrvine.customerservice@seaspine.com
Phone+1(800)550-7155
EmailIrvine.customerservice@seaspine.com
Phone+1(800)550-7155
EmailIrvine.customerservice@seaspine.com
Phone+1(800)550-7155
EmailIrvine.customerservice@seaspine.com
Phone+1(800)550-7155
EmailIrvine.customerservice@seaspine.com
Phone+1(800)550-7155
EmailIrvine.customerservice@seaspine.com
Phone+1(800)550-7155
EmailIrvine.customerservice@seaspine.com
Phone+1(800)550-7155
EmailIrvine.customerservice@seaspine.com
Phone+1(800)550-7155
EmailIrvine.customerservice@seaspine.com
Phone+1(800)550-7155
EmailIrvine.customerservice@seaspine.com
Phone+1(800)550-7155
EmailIrvine.customerservice@seaspine.com
Phone+1(800)550-7155
EmailIrvine.customerservice@seaspine.com

Device Dimensions

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Device Size Text, specify0
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Operating and Storage Conditions

Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS110889981055943 [Primary]
HIBCCM386CCM102101 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MQVFILLER, BONE VOID, CALCIUM COMPOUND

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-09-24

On-Brand Devices [IsoTis Mozaik Strip]

M386CCM102561IsoTis Mozaik™ Strip, 15cc - a resorbable bone void filler made from a bovine collagen matrix
M386CCM102101IsoTis Mozaik™ Strip, 10cc - a resorbable bone void filler made from a bovine collagen matrix
M386CCM101551IsoTis Mozaik™ Strip, 5cc - a resorbable bone void filler made from a bovine collagen matrix t

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