SurgiCase O-02-0-557000-0011-300

GUDID E314O0205570000011300

Total Hip Arthroplasty

Materialise NV

Custom-made organ/bone anatomy model/surgical guide kit
Primary Device IDE314O0205570000011300
NIH Device Record Key1ebc776a-e486-427d-83bd-11d623d7b9d7
Commercial Distribution Discontinuation2017-07-21
Commercial Distribution StatusNot in Commercial Distribution
Brand NameSurgiCase
Version Model NumberO-02-0-557000-0011-300
Catalog NumberO-02-0-557000-0011-300
Company DUNS373139427
Company NameMaterialise NV
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 Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCE314O0205570000011300 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PLWAcetabular Cup Orientation System

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[E314O0205570000011300]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-11-27
Device Publish Date2016-09-24

On-Brand Devices [SurgiCase]

E314SURGICASECONNECTIP0SurgiCase Connect (iPad)
E314SURGICASECONNECT0SurgiCase Connect
E314SURGICASECMF0SurgiCase CMF
E314UEAMA1000010Anatomical model, Pediatric
E314UEAMA0100010Radius/ulna osteotomy, Pediatric
E314O02055700000113000Total Hip Arthroplasty
E314O0205570000011300Total Hip Arthroplasty
E314O01082800000110000Clavicle Osteotomy
E314O01030600000110100Femur Osteotomy
E314O0103060000011010Femur Osteotomy
E314O01030300000110100Tibia/Fibula Osteotomy
E314O0103030000011010Tibia/Fibula Osteotomy
E314O01020000000110100'Hand Osteotomy
E314O01010500000110100Humerus Osteotomy
E314O0101050000011010Humerus Osteotomy
E314O01010100000110100Radius/ulna osteotomy
E314O0101010000011010Radius/ulna osteotomy
E314O00300000000010000Bone models
E314H00877000000010000HeartPrint anatomical model
E314H0087700000001000HeartPrint anatomical model
E314C00390000000110000Anatomical model
E314C0039000000011000Anatomical model

Trademark Results [SurgiCase]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SURGICASE
SURGICASE
79226336 5635087 Live/Registered
Materialise
2017-09-14
SURGICASE
SURGICASE
79091462 4004656 Live/Registered
Materialise N.V.
2010-11-17
SURGICASE
SURGICASE
79048906 3608979 Dead/Cancelled
Materialise N.V.
2007-11-26

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