RegenaVate™ Formable DBM, 1cm x 1cm x 0.5cm, 0.5cc 001504Z

GUDID 00854095006788

Formable DBM, 1cm x 1cm x 0.5cm, 0.5cc

Rti Surgical, Inc.

Bone matrix implant, human-derived
Primary Device ID00854095006788
NIH Device Record Keya04a6b4e-dac8-40e4-b877-160cffdd91b5
Commercial Distribution StatusIn Commercial Distribution
Brand NameRegenaVate™ Formable DBM, 1cm x 1cm x 0.5cm, 0.5cc
Version Model NumberZR0305
Catalog Number001504Z
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 1 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 37 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 37 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100854095006788 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NUNBONE GRAFTING MATERIAL, HUMAN SOURCE

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 [RegenaVate™ Formable DBM, 1cm x 1cm x 0.5cm, 0.5cc]

00854095006788Formable DBM, 1cm x 1cm x 0.5cm, 0.5cc
00191083045078ZR0305

Trademark Results [RegenaVate]

Mark Image

Registration | Serial
Company
Trademark
Application Date
REGENAVATE
REGENAVATE
87765338 5877125 Live/Registered
Genevieve Mack
2018-01-22
REGENAVATE
REGENAVATE
86210321 4778232 Live/Registered
Zimmer Dental Inc.
2014-03-04

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