Femoral Trial PS Insert

GUDID 09348215042202

SIGNATURE ORTHOPAEDICS PTY LTD

Surgical implant template, reusable

• Primary Device ID: 09348215042202
• NIH Device Record Key: b2fb9ead-cd13-4726-9beb-fac9c0fdeb92
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Femoral Trial PS Insert
• Version Model Number: 122-10-0337
• 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	09348215042202 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170613

FDA Product Code

• HWT: Template

Sterilization

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

[09348215042202]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-06-13
• Device Publish Date: 2018-10-05

On-Brand Devices [Femoral Trial PS Insert ]

• 09348215042202: 122-10-0337
• 09348215042196: 122-10-0336
• 09348215042189: 122-10-0335
• 09348215042172: 122-10-0334
• 09348215042165: 122-10-0333
• 09348215042158: 122-10-0332
• 09348215042141: 122-10-0331