OsteoStrux® 56070050ITL

GUDID 10889981123338

OsteoStrux® Putty, 5cc

SEASPINE ORTHOPEDICS CORPORATION

Bone matrix implant, composite
Primary Device ID10889981123338
NIH Device Record Key2a99e299-eee0-46bb-89d0-48e987492a60
Commercial Distribution StatusIn Commercial Distribution
Brand NameOsteoStrux®
Version Model Number56070050ITL
Catalog Number56070050ITL
Company DUNS079840876
Company NameSEASPINE ORTHOPEDICS CORPORATION
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@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

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Operating and Storage Conditions

Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS110889981123338 [Primary]

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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-10-27
Device Publish Date2020-10-19

On-Brand Devices [OsteoStrux®]

10889981123376OsteoStrux® Strip, 15cc
10889981123369OsteoStrux® Strip, 10cc
10889981123352OsteoStrux® Putty, 15cc
10889981123345OsteoStrux® Putty, 10cc
10889981123338OsteoStrux® Putty, 5cc
10889981123321OsteoStrux® Putty, 2.5cc

Trademark Results [OsteoStrux]

Mark Image

Registration | Serial
Company
Trademark
Application Date
OSTEOSTRUX
OSTEOSTRUX
77837871 3881271 Live/Registered
SEASPINE ORTHOPEDICS CORPORATION
2009-09-30

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