Neuro & Craniofacial Fixation System

GUDID M711CRT102ST0

CP Ti

Innovasis, Inc.

Cranioplasty plate, alterable
Primary Device IDM711CRT102ST0
NIH Device Record Keyb166f60e-6584-467e-9f7e-034c09afb25a
Commercial Distribution StatusIn Commercial Distribution
Brand NameNeuro & Craniofacial Fixation System
Version Model NumberCRT102ST
Company DUNS156567492
Company NameInnovasis, Inc.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone801-261-2236
Emailinfo@innovasis.com
Phone801-261-2236
Emailinfo@innovasis.com
Phone801-261-2236
Emailinfo@innovasis.com
Phone801-261-2236
Emailinfo@innovasis.com
Phone801-261-2236
Emailinfo@innovasis.com
Phone801-261-2236
Emailinfo@innovasis.com
Phone801-261-2236
Emailinfo@innovasis.com
Phone801-261-2236
Emailinfo@innovasis.com
Phone801-261-2236
Emailinfo@innovasis.com
Phone801-261-2236
Emailinfo@innovasis.com
Phone801-261-2236
Emailinfo@innovasis.com
Phone801-261-2236
Emailinfo@innovasis.com
Phone801-261-2236
Emailinfo@innovasis.com
Phone801-261-2236
Emailinfo@innovasis.com
Phone801-261-2236
Emailinfo@innovasis.com
Phone801-261-2236
Emailinfo@innovasis.com
Phone801-261-2236
Emailinfo@innovasis.com
Phone801-261-2236
Emailinfo@innovasis.com
Phone801-261-2236
Emailinfo@innovasis.com
Phone801-261-2236
Emailinfo@innovasis.com
Phone801-261-2236
Emailinfo@innovasis.com
Phone801-261-2236
Emailinfo@innovasis.com

Device Dimensions

Length17 Millimeter
Length17 Millimeter
Length17 Millimeter
Length17 Millimeter
Length17 Millimeter
Length17 Millimeter
Length17 Millimeter
Length17 Millimeter
Length17 Millimeter
Length17 Millimeter
Length17 Millimeter
Length17 Millimeter
Length17 Millimeter
Length17 Millimeter
Length17 Millimeter
Length17 Millimeter
Length17 Millimeter
Length17 Millimeter
Length17 Millimeter
Length17 Millimeter
Length17 Millimeter
Length17 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM711CRT102ST0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GWOPlate, Cranioplasty, Preformed, Alterable

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[M711CRT102ST0]

Moist Heat or Steam Sterilization


[M711CRT102ST0]

Moist Heat or Steam Sterilization


[M711CRT102ST0]

Moist Heat or Steam Sterilization


[M711CRT102ST0]

Moist Heat or Steam Sterilization


[M711CRT102ST0]

Moist Heat or Steam Sterilization


[M711CRT102ST0]

Moist Heat or Steam Sterilization


[M711CRT102ST0]

Moist Heat or Steam Sterilization


[M711CRT102ST0]

Moist Heat or Steam Sterilization


[M711CRT102ST0]

Moist Heat or Steam Sterilization


[M711CRT102ST0]

Moist Heat or Steam Sterilization


[M711CRT102ST0]

Moist Heat or Steam Sterilization


[M711CRT102ST0]

Moist Heat or Steam Sterilization


[M711CRT102ST0]

Moist Heat or Steam Sterilization


[M711CRT102ST0]

Moist Heat or Steam Sterilization


[M711CRT102ST0]

Moist Heat or Steam Sterilization


[M711CRT102ST0]

Moist Heat or Steam Sterilization


[M711CRT102ST0]

Moist Heat or Steam Sterilization


[M711CRT102ST0]

Moist Heat or Steam Sterilization


[M711CRT102ST0]

Moist Heat or Steam Sterilization


[M711CRT102ST0]

Moist Heat or Steam Sterilization


[M711CRT102ST0]

Moist Heat or Steam Sterilization


[M711CRT102ST0]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2021-02-05
Device Publish Date2017-07-31

On-Brand Devices [Neuro & Craniofacial Fixation System]

M711CRT16040Ti 6Al 4V (ELI)
M711CRT14050Ti 6Al 4V (ELI)
M711CRT14040Ti 6Al 4V (ELI)
M711CRT14030Ti 6Al 4V (ELI)
M711CRT106DY0CP Ti
M711CRT104ST0CP Ti
M711CRT104SQ0CP Ti
M711CRT102ST0CP Ti
M711CRT100UT030CP Ti
M711CRT042BR0CP Ti
M711CRT041BR0CP Ti
M711CRT040BR0CP Ti
M711CRT032BR0CP Ti
M711CRT031BR0CP Ti
M711CRT030BR0CP Ti
M711CRT020GP0CP Ti
M711CRT006ST0CP Ti
M711CRT006DY0CP Ti
M711CRT004ST0CP Ti
M711CRT004SQ0CP Ti
M711CRT002ST0CP Ti
M711CR19040Ti 6Al 4V (ELI)
M711CR16050Ti 6Al 4V (ELI)
M711CR16040Ti 6Al 4V (ELI)
M711CR16030Ti 6Al 4V (ELI)
M711CR104SQ0CP Ti
M711CR102ST0CP Ti
M711CR100MD060CP Ti
M711CR030GP0CP Ti
M711CR021BR0CP Ti
M711CR020GP0CP Ti
M711CR020BR0CP Ti
M711CR011BR0CP Ti
M711CR010GP0CP Ti
M711CR010BR0CP Ti
M711CR006ST0CP Ti
M711CR006DY0CP Ti
M711CR004ST0CP Ti
M711CR004SQ0CP Ti
M711CR002ST0CP Ti
M711BTA1410Al
M711BTA1400Al
M711BTA1390Al, Radel
M711BTA1380Al
M711BTA1370Al
M711BTA1360Al
M711BTA1350Al
M711BTA1340Al, Radel
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