Logical 20° Hooded Liner

GUDID 09348215026202

SIGNATURE ORTHOPAEDICS PTY LTD

Non-constrained polyethylene acetabular liner

• Primary Device ID: 09348215026202
• NIH Device Record Key: 1ffa18f7-6199-4ee1-8558-6f0ae959f48a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Logical 20° Hooded Liner
• Version Model Number: 111-12-9656
• 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	09348215026202 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-08-10
• Device Publish Date: 2023-08-02

On-Brand Devices [Logical 20° Hooded Liner]

• 09348215095260: 01-041-05-0540
• 09348215095253: 01-041-05-0440
• 09348215095246: 01-041-05-0536
• 09348215095239: 01-041-05-0436
• 09348215095222: 01-041-05-0236
• 09348215095192: 01-041-05-0232
• 09348215095185: 01-041-05-0132
• 09348215095161: 01-041-05-0128
• 09348215095154: 01-041-05-0028
• 09348215024864: 111-12-9460
• 09348215024857: 111-12-9456
• 09348215024840: 111-12-9660
• 09348215024833: 111-12-9656
• 09348215024826: 111-12-9652
• 09348215024819: 111-12-9260
• 09348215024802: 111-12-9256
• 09348215024796: 111-12-9252
• 09348215024789: 111-12-9250
• 09348215024772: 111-12-9852
• 09348215024765: 111-12-9850
• 09348215024758: 111-12-9844
• 09348215026233: 111-12-9460
• 09348215026226: 111-12-9456
• 09348215026219: 111-12-9660
• 09348215026202: 111-12-9656
• 09348215026196: 111-12-9652
• 09348215026189: 111-12-9260
• 09348215026172: 111-12-9256
• 09348215026165: 111-12-9252
• 09348215026158: 111-12-9250
• 09348215026141: 111-12-9852
• 09348215026134: 111-12-9850
• 09348215026127: 111-12-9844