OsteoSurge 100 Putty 56300100

GUDID M386563001001

OsteoSurge100, 10cc - demineralized human bone mixed with poloxamer reverse phase medium. OsteoSurge100 is formulated into a putty form and is provide

ISOTIS ORTHOBIOLOGICS, INC.

Bone matrix implant, human-derived
Primary Device IDM386563001001
NIH Device Record Keyc4f13c54-9053-4d2e-8dea-2aab69c265fd
Commercial Distribution StatusIn Commercial Distribution
Brand NameOsteoSurge 100 Putty
Version Model Number56300100
Catalog Number56300100
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 Producttrue
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
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

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS110889981055820 [Primary]
HIBCCM386563001001 [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 [OsteoSurge 100 Putty]

M386563001001OsteoSurge100, 10cc - demineralized human bone mixed with poloxamer reverse phase medium. OsteoS
M386563000501OsteoSurge100, 5cc - demineralized human bone mixed with poloxamer reverse phase medium. OsteoSu
M386563000251OsteoSurge100, 2.5cc - demineralized human bone mixed with poloxamer reverse phase medium. Osteo
M386563000101OsteoSurge100, 1cc - demineralized human bone mixed with poloxamer reverse phase medium. OsteoSu

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