AccuShape® Titanium Patient-Specific Implant ZB-AST10

GUDID 00810007630991

Titanium Cranial Implant, Small

Medcad

Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable
Primary Device ID00810007630991
NIH Device Record Key97f0ba20-cf68-4c49-bd5a-46022dfbfcfd
Commercial Distribution StatusIn Commercial Distribution
Brand NameAccuShape® Titanium Patient-Specific Implant
Version Model NumberZB-AST10
Catalog NumberZB-AST10
Company DUNS144723868
Company NameMedcad
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
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

Phone2144538864
Emailsupport@medcad.com
Phone2144538864
Emailsupport@medcad.com
Phone2144538864
Emailsupport@medcad.com
Phone2144538864
Emailsupport@medcad.com
Phone2144538864
Emailsupport@medcad.com
Phone2144538864
Emailsupport@medcad.com
Phone2144538864
Emailsupport@medcad.com
Phone2144538864
Emailsupport@medcad.com
Phone2144538864
Emailsupport@medcad.com
Phone2144538864
Emailsupport@medcad.com
Phone2144538864
Emailsupport@medcad.com
Phone2144538864
Emailsupport@medcad.com
Phone2144538864
Emailsupport@medcad.com
Phone2144538864
Emailsupport@medcad.com
Phone2144538864
Emailsupport@medcad.com
Phone2144538864
Emailsupport@medcad.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100810007630991 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GXNPlate, Cranioplasty, Preformed, Non-Alterable

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810007630991]

Moist Heat or Steam Sterilization


[00810007630991]

Moist Heat or Steam Sterilization


[00810007630991]

Moist Heat or Steam Sterilization


[00810007630991]

Moist Heat or Steam Sterilization


[00810007630991]

Moist Heat or Steam Sterilization


[00810007630991]

Moist Heat or Steam Sterilization


[00810007630991]

Moist Heat or Steam Sterilization


[00810007630991]

Moist Heat or Steam Sterilization


[00810007630991]

Moist Heat or Steam Sterilization


[00810007630991]

Moist Heat or Steam Sterilization


[00810007630991]

Moist Heat or Steam Sterilization


[00810007630991]

Moist Heat or Steam Sterilization


[00810007630991]

Moist Heat or Steam Sterilization


[00810007630991]

Moist Heat or Steam Sterilization


[00810007630991]

Moist Heat or Steam Sterilization


[00810007630991]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-09-22
Device Publish Date2022-09-14

On-Brand Devices [AccuShape® Titanium Patient-Specific Implant]

00810007631066Titanium Cranial Implant, Extra Large
00810007631059Titanium Cranial Implant, Large
00810007630991Titanium Cranial Implant, Small

Trademark Results [AccuShape]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ACCUSHAPE
ACCUSHAPE
90236922 not registered Live/Pending
Vanduzen, Inc. DBA Medcad
2020-10-06
ACCUSHAPE
ACCUSHAPE
88882839 not registered Live/Pending
Accushape, Inc.
2020-04-22
ACCUSHAPE
ACCUSHAPE
85420216 4298936 Dead/Cancelled
Medcad
2011-09-12
ACCUSHAPE
ACCUSHAPE
77686005 not registered Dead/Abandoned
lutronic, Inc
2009-03-08
ACCUSHAPE
ACCUSHAPE
73324550 1218974 Dead/Cancelled
Radiation Systems Incorporated
1981-08-20

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