RTI Allograft Paste

GUDID 00854095006979

Allograft Paste 10cc

Rti Surgical, Inc.

Bone matrix implant, human-derived
Primary Device ID00854095006979
NIH Device Record Keyce2d15f4-25ee-42e5-839b-698290706d50
Commercial Distribution StatusIn Commercial Distribution
Brand NameRTI Allograft Paste
Version Model Number801110
Company DUNS014520584
Company NameRti Surgical, 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
Storage Environment TemperatureBetween -39 Degrees Celsius and -20 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100854095006979 [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 Number3
Public Version Date2018-07-06
Device Publish Date2015-11-06

On-Brand Devices [RTI Allograft Paste]

00854095006993Allograft Strip IC 90mm
00854095006986Allograft Strip IC 50mm
00854095006979Allograft Paste 10cc
00854095006962Allograft Paste 5cc
00854095006955Allograft Paste 1cc

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