MEDPOR TITAN 81042

GUDID 07613327123210

MEDPOR Titan 3D OF, MTB Right Small

Stryker Leibinger GmbH & Co. KG

Polyethylene craniofacial tissue reconstructive material

• Primary Device ID: 07613327123210
• NIH Device Record Key: adb8990d-592b-405c-bdcc-ee6b34cd0a0c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MEDPOR TITAN
• Version Model Number: 81042
• Catalog Number: 81042
• 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

• Height: 13 Millimeter
• Height: 13 Millimeter
• Height: 13 Millimeter
• Height: 13 Millimeter
• Width: 32 Millimeter
• Device Size Text, specify: 0
• Length: 35 Millimeter
• Height: 13 Millimeter
• Width: 32 Millimeter
• Device Size Text, specify: 0
• Length: 35 Millimeter
• Height: 13 Millimeter
• Width: 32 Millimeter
• Device Size Text, specify: 0
• Length: 35 Millimeter
• Height: 13 Millimeter
• Width: 32 Millimeter
• Device Size Text, specify: 0
• Length: 35 Millimeter
• Height: 13 Millimeter
• Width: 32 Millimeter
• Device Size Text, specify: 0
• Length: 35 Millimeter
• Height: 13 Millimeter
• Width: 32 Millimeter
• Device Size Text, specify: 0
• Length: 35 Millimeter
• Height: 13 Millimeter
• Width: 32 Millimeter
• Device Size Text, specify: 0
• Length: 35 Millimeter
• Height: 13 Millimeter
• Width: 32 Millimeter
• Device Size Text, specify: 0
• Length: 35 Millimeter
• Height: 13 Millimeter
• Width: 32 Millimeter
• Device Size Text, specify: 0
• Length: 35 Millimeter
• Height: 13 Millimeter
• Width: 32 Millimeter
• Device Size Text, specify: 0
• Length: 35 Millimeter
• Height: 13 Millimeter
• Width: 32 Millimeter
• Device Size Text, specify: 0
• Length: 35 Millimeter
• Height: 13 Millimeter
• Width: 32 Millimeter
• Device Size Text, specify: 0
• Length: 35 Millimeter
• Height: 13 Millimeter
• Width: 32 Millimeter
• Device Size Text, specify: 0
• Length: 35 Millimeter
• Height: 13 Millimeter
• Width: 32 Millimeter
• Device Size Text, specify: 0
• Length: 35 Millimeter
• Height: 13 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327123210 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142568

FDA Product Code

• JEY: PLATE, BONE

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 TITAN]

• 07613327123296: MEDPOR Titan 3D OF, MTB left Large
• 07613327123234: MEDPOR Titan 3D OF, MTB right Large
• 07613327123227: MEDPOR Titan 3D OF, MTB Left Small
• 07613327123210: MEDPOR Titan 3D OF, MTB Right Small
• 07613252204442: MEDPOR TITAN¿ FAN?- MTB?
• 07613252204435: MEDPOR TITAN¿ FAN?- MTM?
• 07613252084815: Posterior Implant
• 07613252084792: Cranial Curve - BARRIER?
• 07613252084785: Cranial Curve
• 07613252084402: MEDPOR TITAN¿ MAX? Sheet
• 07613252084396: Cranial Temporal with Template ? Right
• 07613252084389: Cranial Temporal with Template - Left
• 07613252084372: MAX? Orbital Floor and Wall MTB? Right
• 07613252084365: MAX? Orbital Floor and Wall MTB? Left
• 07613252084358: MAX? Orbital Floor and Wall MTM?
• 07613252084341: Orbital Floor and Wall BTB?
• 07613252084334: Orbital Floor and Wall MTB? Right
• 07613252084327: Orbital Floor and Wall MTB? Left
• 07613252084310: Orbital Floor and Wall MTM?
• 07613252084303: MEDPOR TITAN¿ BARRIER? (MTB?)
• 07613252084297: MEDPOR TITAN¿ BARRIER? (MTB?)
• 07613252084280: MEDPOR TITAN¿ BARRIER? (MTB?)
• 07613252084273: MEDPOR TITAN¿ BARRIER? (MTB?)
• 07613252084266: MEDPOR TITAN¿ Double BARRIER? (BTB?)
• 07613252084259: MEDPOR TITAN¿ Double BARRIER? (BTB?)
• 07613252084242: MEDPOR TITAN¿ MEDPOR¿ (MTM?)
• 07613252084235: MEDPOR TITAN¿ MEDPOR¿ (MTM?)
• 07613252084228: MEDPOR TITAN¿ MEDPOR¿ (MTM?)
• 07613252084211: MEDPOR TITAN¿ MEDPOR¿ (MTM?)