AccuShape® ACSX-004

GUDID 00810007630076

PEEK Cranial Implant, Extra Large

Medcad

Cranioplasty plate, non-alterable
Primary Device ID00810007630076
NIH Device Record Key04158ff5-d5b6-44c9-9570-92d29d8f971f
Commercial Distribution StatusIn Commercial Distribution
Brand NameAccuShape®
Version Model NumberACSX-004
Catalog NumberACSX-004
Company DUNS144723868
Company NameMedcad
Device Count1
DM Exemptfalse
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 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

Phone(214) 453-8864
Emailsupport@medcad.net

Device Identifiers

Device Issuing AgencyDevice ID
GS100810007630076 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GXNPlate, Cranioplasty, Preformed, Non-Alterable

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810007630076]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-03-11
Device Publish Date2019-02-28

On-Brand Devices [AccuShape®]

00810007630137PEEK Cranial Implant, XXL
00810007630120PEEK Cranial Implant, Extra Large
00810007630113PEEK Cranial Implant, Large
00810007630106PEEK Cranial Implant, Medium
00810007630090PEEK Cranial Implant, Small
00810007630083PEEK Cranial Implant, Extra Small
00810007630076PEEK Cranial Implant, Extra Large
00810007630069PEEK Cranial Implant, Large
00810007630052PEEK Cranial Implant, Medium
00810007630045PEEK Cranial Implant, Small
00810007630038PEEK Cranial Implant, Extra Large
00810007630021PEEK Cranial Implant, Large
00810007630014PEEK Cranial Implant, Medium
00810007630007PEEK Cranial Implant, Small
00810007630175PEEK Cranial Implant, Large
00810007630168PEEK Cranial Implant, Small
00810007630632PEEK Cranial Implant, Extra Large
00810007630625PEEK Cranial Implant, Large
00810007630618PEEK Cranial Implant, Medium
00810007630182PEEK 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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