MEDPOR BARRIER 8312

GUDID 07613252084914

BARRIER? Sheet Implant - Rectangle

Stryker Leibinger GmbH & Co. KG

Polyethylene craniofacial tissue reconstructive material Polyethylene craniofacial tissue reconstructive material Polyethylene craniofacial tissue reconstructive material Polyethylene craniofacial tissue reconstructive material Polyethylene craniofacial tissue reconstructive material Polyethylene craniofacial tissue reconstructive material Polyethylene craniofacial tissue reconstructive material Polyethylene craniofacial tissue reconstructive material Polyethylene craniofacial tissue reconstructive material Polyethylene craniofacial tissue reconstructive material Polyethylene craniofacial tissue reconstructive material Polyethylene craniofacial tissue reconstructive material Polyethylene craniofacial tissue reconstructive material Polyethylene craniofacial tissue reconstructive material Polyethylene craniofacial tissue reconstructive material

• Primary Device ID: 07613252084914
• NIH Device Record Key: 1463c96a-6489-4a07-b604-ab6f7861486b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MEDPOR BARRIER
• Version Model Number: 8312
• Catalog Number: 8312
• 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

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 76 Millimeter
• Width: 50 Millimeter
• Device Size Text, specify: 0
• Length: 76 Millimeter
• Width: 50 Millimeter
• Device Size Text, specify: 0
• Length: 76 Millimeter
• Width: 50 Millimeter
• Device Size Text, specify: 0
• Length: 76 Millimeter
• Width: 50 Millimeter
• Device Size Text, specify: 0
• Length: 76 Millimeter
• Width: 50 Millimeter
• Device Size Text, specify: 0
• Length: 76 Millimeter
• Width: 50 Millimeter
• Device Size Text, specify: 0
• Length: 76 Millimeter
• Width: 50 Millimeter
• Device Size Text, specify: 0
• Length: 76 Millimeter
• Width: 50 Millimeter
• Device Size Text, specify: 0
• Length: 76 Millimeter
• Width: 50 Millimeter
• Device Size Text, specify: 0
• Length: 76 Millimeter
• Width: 50 Millimeter
• Device Size Text, specify: 0
• Length: 76 Millimeter
• Width: 50 Millimeter
• Device Size Text, specify: 0
• Length: 76 Millimeter
• Width: 50 Millimeter
• Device Size Text, specify: 0
• Length: 76 Millimeter
• Width: 50 Millimeter
• Device Size Text, specify: 0
• Length: 76 Millimeter
• Width: 50 Millimeter
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613252084914 [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