Logical G-Series Acetabular Shell

GUDID 09348215052133

SIGNATURE ORTHOPAEDICS PTY LTD

Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell
Primary Device ID09348215052133
NIH Device Record Keyc7d4aa40-e4e4-4bea-bf1a-ab169ed7aeb5
Commercial Distribution StatusIn Commercial Distribution
Brand NameLogical G-Series Acetabular Shell
Version Model NumberD111-12-3354
Company DUNS751993028
Company NameSIGNATURE ORTHOPAEDICS PTY LTD
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
GS109348215052133 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-09-28
Device Publish Date2022-09-20

On-Brand Devices [Logical G-Series Acetabular Shell]

09348215054090D111-12-3970
09348215054083D111-12-3968
09348215054076D111-12-3966
09348215054069D111-12-3964
09348215054052D111-12-3962
09348215054045D111-12-3960
09348215054038D111-12-3958
09348215054021D111-12-3956
09348215054014D111-12-3954
09348215054007D111-12-3952
09348215053994D111-12-3950
09348215053987D111-12-3948
09348215053970D111-12-3946
09348215053963D111-12-3944
09348215053956D111-12-3346
09348215053949D111-12-3344
09348215053932D111-12-3070
09348215053925D111-12-3068
09348215053918D111-12-3066
09348215053901D111-12-3064
09348215053895D111-12-3062
09348215053888D111-12-3060
09348215053871D111-12-3058
09348215053864D111-12-3056
09348215053857D111-12-3054
09348215053840D111-12-3052
09348215053833D111-12-3050
09348215053826D111-12-3048
09348215053819D111-12-3046
09348215053802D111-12-3044
09348215053789D111-12-3355
09348215052645D111-12-3351
09348215052218D111-12-3370
09348215052201D111-12-3368
09348215052195D111-12-3366
09348215052188D111-12-3364
09348215052171D111-12-3362
09348215052164D111-12-3360
09348215052157D111-12-3358
09348215052140D111-12-3356
09348215052133D111-12-3354
09348215052126D111-12-3352
09348215052119D111-12-3350
09348215052102D111-12-3348
0934821509465201-040-02-0570
0934821509464501-040-02-0568
0934821509463801-040-02-0566
0934821509462101-040-02-0564
0934821509461401-040-02-0562
0934821509460701-040-02-0560

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