Logical C-Series

GUDID 09348215005016

SIGNATURE ORTHOPAEDICS PTY LTD

Acetabular shell

• Primary Device ID: 09348215005016
• NIH Device Record Key: f4a40945-b6c2-4300-a89d-ea51be74ee5d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Logical C-Series
• Version Model Number: 111-12-4066
• 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	09348215005016 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153131

FDA Product Code

• KWZ: Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer

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: 2016-07-07

On-Brand Devices [Logical C-Series]

• 09348215005351: 111-12-4970
• 09348215005344: 111-12-4968
• 09348215005337: 111-12-4966
• 09348215005320: 111-12-4964
• 09348215005313: 111-12-4962
• 09348215005306: 111-12-4960
• 09348215005290: 111-12-4958
• 09348215005283: 111-12-4956
• 09348215005276: 111-12-4954
• 09348215005269: 111-12-4952
• 09348215005252: 111-12-4950
• 09348215005245: 111-12-4948
• 09348215005238: 111-12-4946
• 09348215005221: 111-12-4944
• 09348215005191: 111-12-4370
• 09348215005184: 111-12-4368
• 09348215005177: 111-12-4366
• 09348215005160: 111-12-4364
• 09348215005153: 111-12-4362
• 09348215005146: 111-12-4360
• 09348215005139: 111-12-4358
• 09348215005122: 111-12-4356
• 09348215005115: 111-12-4354
• 09348215005108: 111-12-4352
• 09348215005092: 111-12-4350
• 09348215005085: 111-12-4348
• 09348215005078: 111-12-4346
• 09348215005061: 111-12-4344
• 09348215005030: 111-12-4070
• 09348215005023: 111-12-4068
• 09348215005016: 111-12-4066
• 09348215005009: 111-12-4064
• 09348215004996: 111-12-4062
• 09348215004989: 111-12-4060
• 09348215004972: 111-12-4058
• 09348215004965: 111-12-4056
• 09348215004958: 111-12-4054
• 09348215004941: 111-12-4052
• 09348215004934: 111-12-4050
• 09348215004927: 111-12-4048
• 09348215004910: 111-12-4046
• 09348215004903: 111-12-4044