MEDPOR TITAN 81021

GUDID 07613252084228

MEDPOR TITAN¿ MEDPOR¿ (MTM?)

Stryker Leibinger GmbH & Co. KG

Polyethylene craniofacial tissue reconstructive material

Primary Device ID	07613252084228
NIH Device Record Key	6c72c83b-d78b-4bb6-b388-cf4827514c68
Commercial Distribution Status	In Commercial Distribution
Brand Name	MEDPOR TITAN
Version Model Number	81021
Catalog Number	81021
Company DUNS	316153956
Company Name	Stryker Leibinger GmbH & Co. KG
Device Count	1
DM Exempt	true
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	50 Millimeter
Length	38 Millimeter
Device Size Text, specify	0
Width	50 Millimeter
Length	38 Millimeter
Device Size Text, specify	0
Width	50 Millimeter
Length	38 Millimeter
Device Size Text, specify	0
Width	50 Millimeter
Length	38 Millimeter
Device Size Text, specify	0
Width	50 Millimeter
Length	38 Millimeter
Device Size Text, specify	0
Width	50 Millimeter
Length	38 Millimeter
Device Size Text, specify	0
Width	50 Millimeter
Length	38 Millimeter
Device Size Text, specify	0
Width	50 Millimeter
Length	38 Millimeter
Device Size Text, specify	0
Width	50 Millimeter
Length	38 Millimeter
Device Size Text, specify	0
Width	50 Millimeter
Length	38 Millimeter
Device Size Text, specify	0
Width	50 Millimeter
Length	38 Millimeter
Device Size Text, specify	0
Width	50 Millimeter
Length	38 Millimeter
Device Size Text, specify	0
Width	50 Millimeter
Length	38 Millimeter
Device Size Text, specify	0
Width	50 Millimeter
Length	38 Millimeter
Device Size Text, specify	0
Width	50 Millimeter
Length	38 Millimeter
Device Size Text, specify	0
Width	50 Millimeter
Length	38 Millimeter
Device Size Text, specify	0
Width	50 Millimeter
Length	38 Millimeter
Device Size Text, specify	0
Width	50 Millimeter
Length	38 Millimeter
Device Size Text, specify	0
Width	50 Millimeter
Length	38 Millimeter
Device Size Text, specify	0
Width	50 Millimeter
Length	38 Millimeter
Device Size Text, specify	0
Width	50 Millimeter
Length	38 Millimeter
Device Size Text, specify	0
Width	50 Millimeter
Length	38 Millimeter
Device Size Text, specify	0
Width	50 Millimeter
Length	38 Millimeter
Device Size Text, specify	0
Width	50 Millimeter
Length	38 Millimeter
Device Size Text, specify	0
Width	50 Millimeter
Length	38 Millimeter
Device Size Text, specify	0
Width	50 Millimeter
Length	38 Millimeter
Device Size Text, specify	0
Width	50 Millimeter
Length	38 Millimeter
Device Size Text, specify	0
Width	50 Millimeter
Length	38 Millimeter
Device Size Text, specify	0
Width	50 Millimeter
Length	38 Millimeter
Device Size Text, specify	0
Width	50 Millimeter
Length	38 Millimeter
Device Size Text, specify	0
Width	50 Millimeter
Length	38 Millimeter
Device Size Text, specify	0

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613252084228 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K040364

FDA Product Code

FTM	Mesh, surgical

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	2
Public Version Date	2018-03-29
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?)

Trademark Results [MEDPOR TITAN]

Mark Image Registration \| Serial	Company Trademark Application Date
MEDPOR TITAN 77664828 3672477 Live/Registered	ORTHOVITA, INC. 2009-02-06