Logical Lateralised 20° Hooded Liner

GUDID 09348215095383

SIGNATURE ORTHOPAEDICS PTY LTD

Non-constrained polyethylene acetabular liner Non-constrained polyethylene acetabular liner Non-constrained polyethylene acetabular liner Non-constrained polyethylene acetabular liner Non-constrained polyethylene acetabular liner Non-constrained polyethylene acetabular liner Non-constrained polyethylene acetabular liner Non-constrained polyethylene acetabular liner Non-constrained polyethylene acetabular liner Non-constrained polyethylene acetabular liner Non-constrained polyethylene acetabular liner Non-constrained polyethylene acetabular liner Non-constrained polyethylene acetabular liner Non-constrained polyethylene acetabular liner Non-constrained polyethylene acetabular liner

• Primary Device ID: 09348215095383
• NIH Device Record Key: 9d461ae5-a4f9-40fe-bbff-6fa9db6d3cab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Logical Lateralised 20° Hooded Liner
• Version Model Number: 01-041-06-0540
• 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	09348215095383 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153131

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 Lateralised 20° Hooded Liner]

• 09348215095383: 01-041-06-0540
• 09348215095376: 01-041-06-0440
• 09348215095369: 01-041-06-0536
• 09348215095352: 01-041-06-0436
• 09348215095345: 01-041-06-0236
• 09348215095314: 01-041-06-0232
• 09348215095307: 01-041-06-0132
• 09348215095284: 01-041-06-0128
• 09348215095277: 01-041-06-0028