Logical G-Series

GUDID 09348215094416

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 ID	09348215094416
NIH Device Record Key	56985437-3c14-4832-8ab0-73f6752bdcdb
Commercial Distribution Status	In Commercial Distribution
Brand Name	Logical G-Series
Version Model Number	01-040-01-0254
Company DUNS	751993028
Company Name	SIGNATURE ORTHOPAEDICS PTY LTD
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	09348215094416 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K121297

FDA Product Code

LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2022-03-18
Device Publish Date	2022-03-10

On-Brand Devices [Logical G-Series]

09348215024727	111-12-3355
09348215024246	111-12-3351
09348215006228	111-12-3970
09348215006211	111-12-3968
09348215006204	111-12-3966
09348215006198	111-12-3964
09348215006181	111-12-3962
09348215006174	111-12-3960
09348215006167	111-12-3958
09348215006150	111-12-3956
09348215006143	111-12-3954
09348215006136	111-12-3952
09348215006129	111-12-3950
09348215006112	111-12-3948
09348215006105	111-12-3946
09348215006099	111-12-3944
09348215006068	111-12-3370
09348215006051	111-12-3070
09348215000950	111-12-3368
09348215000943	111-12-3366
09348215000936	111-12-3364
09348215000929	111-12-3362
09348215000912	111-12-3360
09348215000905	111-12-3358
09348215000899	111-12-3356
09348215000882	111-12-3354
09348215000875	111-12-3352
09348215000868	111-12-3350
09348215000851	111-12-3348
09348215000844	111-12-3346
09348215000837	111-12-3344
09348215000790	111-12-3068
09348215000783	111-12-3066
09348215000776	111-12-3064
09348215000769	111-12-3062
09348215000752	111-12-3060
09348215000745	111-12-3058
09348215000738	111-12-3056
09348215000721	111-12-3054
09348215000714	111-12-3052
09348215000707	111-12-3050
09348215000691	111-12-3048
09348215000684	111-12-3046
09348215000677	111-12-3044
09348215094492	01-040-01-0568
09348215094485	01-040-01-0566
09348215094478	01-040-01-0564
09348215094461	01-040-01-0562
09348215094454	01-040-01-0560
09348215094447	01-040-01-0458