Optimized Ortho Positioning (OPS) Femoral

GUDID 09351327000039

Patient Specific Femoral Guide

OPTIMIZED ORTHO PTY LTD

Custom-made orthopaedic surgical guide, non-sterile

• Primary Device ID: 09351327000039
• NIH Device Record Key: 22086808-05b1-4e77-8692-bac7cff334f2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Optimized Ortho Positioning (OPS) Femoral
• Version Model Number: 1250-1100
• Company DUNS: 745735175
• Company Name: OPTIMIZED ORTHO 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	09351327000039 [Primary]

FDA Product Code

• PBF: Orthopaedic Surgical Planning And Instrument Guides

Sterilization

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

[09351327000039]

Moist Heat or Steam Sterilization

[09351327000039]

Moist Heat or Steam Sterilization

[09351327000039]

Moist Heat or Steam Sterilization

[09351327000039]

Moist Heat or Steam Sterilization

[09351327000039]

Moist Heat or Steam Sterilization

[09351327000039]

Moist Heat or Steam Sterilization

[09351327000039]

Moist Heat or Steam Sterilization

[09351327000039]

Moist Heat or Steam Sterilization

[09351327000039]

Moist Heat or Steam Sterilization

[09351327000039]

Moist Heat or Steam Sterilization

[09351327000039]

Moist Heat or Steam Sterilization

[09351327000039]

Moist Heat or Steam Sterilization

[09351327000039]

Moist Heat or Steam Sterilization

[09351327000039]

Moist Heat or Steam Sterilization

[09351327000039]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-04-22
• Device Publish Date: 2019-04-12

On-Brand Devices [Optimized Ortho Positioning (OPS) Femoral]

• 09351327000046: Trial Femoral Head
• 09351327000039: Patient Specific Femoral Guide