Orthoblast II Paste 02-2100-080

GUDID M3860221000801

OrthoBlast II Paste, 8cc - derived from selected donated human bone tissue that has been processed into particles. The particles are subsequently demi

ISOTIS ORTHOBIOLOGICS, INC.

Bone matrix implant, human-derived
Primary Device IDM3860221000801
NIH Device Record Key06fcc750-1ab2-40cd-999e-17293267d7db
Commercial Distribution StatusIn Commercial Distribution
Brand NameOrthoblast II Paste
Version Model Number02-2100-080
Catalog Number02-2100-080
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
GS110889981055615 [Primary]
HIBCCM3860221000801 [Secondary]

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 Number2
Public Version Date2018-03-29
Device Publish Date2015-09-24

On-Brand Devices [Orthoblast II Paste]

M3860221000801OrthoBlast II Paste, 8cc - derived from selected donated human bone tissue that has been process
M3860221000301OrthoBlast II Paste, 3cc - derived from selected donated human bone tissue that has been process
M3860221000101OrthoBlast II Paste, 1cc - derived from selected donated human bone tissue that has been process
M3860221000051OrthoBlast II Paste, 0.5cc - derived from selected donated human bone tissue that has been proce

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