Tutopatch™ bovine pericardium10x12.5 cm BP1013

GUDID 04041543311891

Bovine Pericardium 10 x 12.5 cm

Tutogen Medical GmbH

Extra-gynaecological surgical mesh, collagen, bioabsorbable
Primary Device ID04041543311891
NIH Device Record Key6b147dee-9bb4-424d-b9d2-0317e5d3c6a5
Commercial Distribution StatusIn Commercial Distribution
Brand NameTutopatch™ bovine pericardium10x12.5 cm
Version Model NumberBP1013
Catalog NumberBP1013
Company DUNS343337499
Company NameTutogen Medical GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS104041543311891 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DXZPATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2022-06-10
Device Publish Date2015-12-14

Devices Manufactured by Tutogen Medical GmbH

04041543311846 - Tutopatch™ bovine pericardium 6x8 cm2022-06-10 Bovine pericardium 6 x 8 cm
04041543311853 - Tutopatch™ bovine pericardium 8x11 cm2022-06-10 Bovine Pericardium 8 x 11 cm
04041543311860 - Tutopatch™ bovine pericardium 8x14 cm2022-06-10 Bovine pericardium 8 x 14 cm
04041543311877 - Tutopatch™ bovine pericardium 8x16 cm2022-06-10 Bovine Pericardium 8 x 16 cm
04041543311884 - Tutopatch™ bovine pericardium 8x18 cm2022-06-10 Bovine Pericardium 8 x 18 cm
04041543311891 - Tutopatch™ bovine pericardium10x12.5 cm2022-06-10Bovine Pericardium 10 x 12.5 cm
04041543311891 - Tutopatch™ bovine pericardium10x12.5 cm2022-06-10 Bovine Pericardium 10 x 12.5 cm
04041543311907 - Tutopatch™ bovine pericardium 10x16 cm2022-06-10 Bovine Pericardium 10 x 16cm
04041543311914 - Tutopatch™ bovine pericardium 12x12 cm2022-06-10 Bovine Pericardium 12 x 12 cm

Trademark Results [Tutopatch]

Mark Image

Registration | Serial
Company
Trademark
Application Date
TUTOPATCH
TUTOPATCH
86347755 4793194 Live/Registered
RTI Surgical, Inc.
2014-07-25
TUTOPATCH
TUTOPATCH
78220765 2881435 Dead/Cancelled
Tutogen Medical GmbH
2003-03-03

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.