RTI Allograft Paste

GUDID 00854095006955

Allograft Paste 1cc

Rti Surgical, Inc.

Bone matrix implant, human-derived
Primary Device ID00854095006955
NIH Device Record Key90db2727-ed8f-4381-b9d2-fd7c8f31ed94
Commercial Distribution StatusIn Commercial Distribution
Brand NameRTI Allograft Paste
Version Model Number801101
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
GS100854095006955 [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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.