MEDPOR BARRIER 9305

GUDID 07613252085799

BARRIER? Sheet Implant - Orbital Floor

Stryker Leibinger GmbH & Co. KG

Polyethylene craniofacial tissue reconstructive material

• Primary Device ID: 07613252085799
• NIH Device Record Key: 8404b063-a94a-4cc6-a7f3-55b63f1d1f23
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MEDPOR BARRIER
• Version Model Number: 9305
• Catalog Number: 9305
• Company DUNS: 316153956
• Company Name: Stryker Leibinger GmbH & Co. KG
• 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 Dimensions

• Width: 38 Millimeter
• Width: 38 Millimeter
• Width: 38 Millimeter
• Device Size Text, specify: 0
• Length: 50 Millimeter
• Width: 38 Millimeter
• Device Size Text, specify: 0
• Length: 50 Millimeter
• Width: 38 Millimeter
• Device Size Text, specify: 0
• Length: 50 Millimeter
• Width: 38 Millimeter
• Device Size Text, specify: 0
• Length: 50 Millimeter
• Width: 38 Millimeter
• Device Size Text, specify: 0
• Length: 50 Millimeter
• Width: 38 Millimeter
• Device Size Text, specify: 0
• Length: 50 Millimeter
• Width: 38 Millimeter
• Device Size Text, specify: 0
• Length: 50 Millimeter
• Width: 38 Millimeter
• Device Size Text, specify: 0
• Length: 50 Millimeter
• Width: 38 Millimeter
• Device Size Text, specify: 0
• Length: 50 Millimeter
• Width: 38 Millimeter
• Device Size Text, specify: 0
• Length: 50 Millimeter
• Width: 38 Millimeter
• Device Size Text, specify: 0
• Length: 50 Millimeter
• Width: 38 Millimeter
• Device Size Text, specify: 0
• Length: 50 Millimeter
• Width: 38 Millimeter
• Device Size Text, specify: 0
• Length: 50 Millimeter
• Width: 38 Millimeter
• Device Size Text, specify: 0
• Length: 50 Millimeter
• Width: 38 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613252085799 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K952677

FDA Product Code

• FWP: PROSTHESIS, CHIN, INTERNAL

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-07-01
• Device Publish Date: 2015-09-24

On-Brand Devices [MEDPOR BARRIER]

• 07613252729860: MEDPOR BARRIER SHEET IMPLANT - T-DESIGN
• 07613252085805: BARRIER? Sheet Implant - Rectangle
• 07613252085799: BARRIER? Sheet Implant - Orbital Floor
• 07613252084914: BARRIER? Sheet Implant - Rectangle
• 07613252084907: BARRIER? Sheet - Orbital Floor Implant