StarPore CI-STARPORE-L

GUDID 09349797000215

StarPore Patient Specific Implant (Large)

ANATOMICS PTY LTD

Polyethylene craniofacial tissue reconstructive material

• Primary Device ID: 09349797000215
• NIH Device Record Key: 307e9cc8-ff93-42f1-9cee-a1c96703814a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: StarPore
• Version Model Number: CI-STARPORE-L
• Catalog Number: CI-STARPORE-L
• Company DUNS: 755739307
• Company Name: ANATOMICS PTY LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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

Customer Support Contacts

• Phone: +61395298088
• Email: contact@anatomics.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	09349797000215 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171037

FDA Product Code

• GWO: Plate, Cranioplasty, Preformed, Alterable

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: 2020-01-16
• Device Publish Date: 2020-01-08

On-Brand Devices [StarPore]

• 09349797000239: StarPore Patient Specific Implant (Other)
• 09349797000222: StarPore Patient Specific Implant (X-Large)
• 09349797000215: StarPore Patient Specific Implant (Large)
• 09349797000208: StarPore Patient Specific Implant (Medium)
• 09349797000192: StarPore Patient Specific Implant (Small)
• 09349797002387: StarPore Patient Specific Implant (SAMPLE)
• 09349797001700: StarPore Patient Specific Implant
• 09349797002561: StarPore Patient Specific Implant (X-Large)
• 09349797002554: StarPore Patient Specific Implant (Large)
• 09349797002547: StarPore Patient Specific Implant (Medium)
• 09349797002530: StarPore Patient Specific Implant (Small)