Logical G-Series

GUDID 09348215006051

SIGNATURE ORTHOPAEDICS PTY LTD

Acetabular shell

• Primary Device ID: 09348215006051
• NIH Device Record Key: 27b0b1d7-e49b-4464-828b-a153ba8a6260
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Logical G-Series
• Version Model Number: 111-12-3070
• 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	09348215006051 [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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-09-09
• Device Publish Date: 2017-09-25

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