RTI Allograft Paste

GUDID 00898623002101

Allograft Paste 0.2cc

Surgalign Spine Technologies, Inc.

Bone matrix implant, human-derived
Primary Device ID00898623002101
NIH Device Record Key336fe9af-c829-4252-a45b-6dabb3f3bd34
Commercial Distribution StatusIn Commercial Distribution
Brand NameRTI Allograft Paste
Version Model Number804002
Company DUNS014520584
Company NameSurgalign Spine Technologies, 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 Numbertrue
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween -39 Degrees Celsius and -20 Degrees Celsius
Storage Environment TemperatureBetween -39 Degrees Celsius and -20 Degrees Celsius
Storage Environment TemperatureBetween -39 Degrees Celsius and -20 Degrees Celsius
Storage Environment TemperatureBetween -39 Degrees Celsius and -20 Degrees Celsius
Storage Environment TemperatureBetween -39 Degrees Celsius and -20 Degrees Celsius
Storage Environment TemperatureBetween -39 Degrees Celsius and -20 Degrees Celsius
Storage Environment TemperatureBetween -39 Degrees Celsius and -20 Degrees Celsius
Storage Environment TemperatureBetween -39 Degrees Celsius and -20 Degrees Celsius
Storage Environment TemperatureBetween -39 Degrees Celsius and -20 Degrees Celsius
Storage Environment TemperatureBetween -39 Degrees Celsius and -20 Degrees Celsius
Storage Environment TemperatureBetween -39 Degrees Celsius and -20 Degrees Celsius
Storage Environment TemperatureBetween -39 Degrees Celsius and -20 Degrees Celsius
Storage Environment TemperatureBetween -39 Degrees Celsius and -20 Degrees Celsius
Storage Environment TemperatureBetween -39 Degrees Celsius and -20 Degrees Celsius
Storage Environment TemperatureBetween -39 Degrees Celsius and -20 Degrees Celsius
Storage Environment TemperatureBetween -39 Degrees Celsius and -20 Degrees Celsius
Storage Environment TemperatureBetween -39 Degrees Celsius and -20 Degrees Celsius
Storage Environment TemperatureBetween -39 Degrees Celsius and -20 Degrees Celsius
Storage Environment TemperatureBetween -39 Degrees Celsius and -20 Degrees Celsius
Storage Environment TemperatureBetween -39 Degrees Celsius and -20 Degrees Celsius
Storage Environment TemperatureBetween -39 Degrees Celsius and -20 Degrees Celsius
Storage Environment TemperatureBetween -39 Degrees Celsius and -20 Degrees Celsius
Storage Environment TemperatureBetween -39 Degrees Celsius and -20 Degrees Celsius
Storage Environment TemperatureBetween -39 Degrees Celsius and -20 Degrees Celsius
Storage Environment TemperatureBetween -39 Degrees Celsius and -20 Degrees Celsius
Storage Environment TemperatureBetween -39 Degrees Celsius and -20 Degrees Celsius
Storage Environment TemperatureBetween -39 Degrees Celsius and -20 Degrees Celsius
Storage Environment TemperatureBetween -39 Degrees Celsius and -20 Degrees Celsius
Storage Environment TemperatureBetween -39 Degrees Celsius and -20 Degrees Celsius
Storage Environment TemperatureBetween -39 Degrees Celsius and -20 Degrees Celsius
Storage Environment TemperatureBetween -39 Degrees Celsius and -20 Degrees Celsius
Storage Environment TemperatureBetween -39 Degrees Celsius and -20 Degrees Celsius
Storage Environment TemperatureBetween -39 Degrees Celsius and -20 Degrees Celsius
Storage Environment TemperatureBetween -39 Degrees Celsius and -20 Degrees Celsius
Storage Environment TemperatureBetween -39 Degrees Celsius and -20 Degrees Celsius
Storage Environment TemperatureBetween -39 Degrees Celsius and -20 Degrees Celsius
Storage Environment TemperatureBetween -39 Degrees Celsius and -20 Degrees Celsius
Storage Environment TemperatureBetween -39 Degrees Celsius and -20 Degrees Celsius
Storage Environment TemperatureBetween -39 Degrees Celsius and -20 Degrees Celsius
Storage Environment TemperatureBetween -39 Degrees Celsius and -20 Degrees Celsius
Storage Environment TemperatureBetween -39 Degrees Celsius and -20 Degrees Celsius
Storage Environment TemperatureBetween -39 Degrees Celsius and -20 Degrees Celsius
Storage Environment TemperatureBetween -39 Degrees Celsius and -20 Degrees Celsius
Storage Environment TemperatureBetween -39 Degrees Celsius and -20 Degrees Celsius
Storage Environment TemperatureBetween -39 Degrees Celsius and -20 Degrees Celsius
Storage Environment TemperatureBetween -39 Degrees Celsius and -20 Degrees Celsius
Storage Environment TemperatureBetween -39 Degrees Celsius and -20 Degrees Celsius
Storage Environment TemperatureBetween -39 Degrees Celsius and -20 Degrees Celsius
Storage Environment TemperatureBetween -39 Degrees Celsius and -20 Degrees Celsius
Storage Environment TemperatureBetween -39 Degrees Celsius and -20 Degrees Celsius
Storage Environment TemperatureBetween -39 Degrees Celsius and -20 Degrees Celsius
Storage Environment TemperatureBetween -39 Degrees Celsius and -20 Degrees Celsius
Storage Environment TemperatureBetween -39 Degrees Celsius and -20 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100898623002101 [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 StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2021-02-05
Device Publish Date2015-11-06

On-Brand Devices [RTI Allograft Paste]

00898623002125Allograft Paste 1cc
00898623002118Allograft Paste 0.5cc
00898623002101Allograft Paste 0.2cc
00898623002095Allograft Paste IC 10cc
00898623002088Allograft Paste IC 5cc
00898623002071Allograft Paste IC, RT, 3cc
00898623002064Allograft Paste IC, RT, 2cc
00898623002057Allograft Paste IC, RT, 1cc
00898623002040Allograft Paste IC 10cc
00898623002033Allograft Paste IC 5cc
00898623002026Allograft Paste 10cc
00898623002019Allograft Paste 5cc
00898623002002Allograft Paste 1cc

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