Trial Liners (20 degree hooded)

GUDID 09348215038816

SIGNATURE ORTHOPAEDICS PTY LTD

Surgical implant template, reusable

• Primary Device ID: 09348215038816
• NIH Device Record Key: 62a2b805-7ca2-402a-9a51-6099bc050a7d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Trial Liners (20 degree hooded)
• Version Model Number: 112-152-528
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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	09348215038816 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153131

FDA Product Code

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

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[09348215038816]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-06-18
• Device Publish Date: 2018-10-02

On-Brand Devices [Trial Liners (20 degree hooded)]

• 09348215038816: 112-152-528
• 09348215038809: 112-152-527
• 09348215038793: 112-152-526
• 09348215038786: 112-152-525
• 09348215038779: 112-152-524
• 09348215038762: 112-152-523
• 09348215038755: 112-152-522
• 09348215038748: 112-152-521
• 09348215038731: 112-152-520
• 09348215038724: 112-152-519
• 09348215038717: 112-152-518
• 09348215038700: 112-152-517
• 09348215038694: 112-152-516