Duatene DTN10RX3

GUDID 20884521726601

Bilayer Mesh Monofilament Polypropylene

SOFRADIM PRODUCTION

Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable
Primary Device ID20884521726601
NIH Device Record Key7d8b81b7-c93d-47e5-ad4f-4e6275f3cf6c
Commercial Distribution StatusIn Commercial Distribution
Brand NameDuatene
Version Model NumberDTN10RX3
Catalog NumberDTN10RX3
Company DUNS576342646
Company NameSOFRADIM PRODUCTION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com

Device Dimensions

Width13 Centimeter
Height6 Centimeter
Outer Diameter10 Centimeter
Device Size Text, specify0
Width13 Centimeter
Height6 Centimeter
Outer Diameter10 Centimeter
Device Size Text, specify0
Width13 Centimeter
Height6 Centimeter
Outer Diameter10 Centimeter
Device Size Text, specify0
Width13 Centimeter
Height6 Centimeter
Outer Diameter10 Centimeter
Device Size Text, specify0
Width13 Centimeter
Height6 Centimeter
Outer Diameter10 Centimeter
Device Size Text, specify0
Width13 Centimeter
Height6 Centimeter
Outer Diameter10 Centimeter
Device Size Text, specify0
Width13 Centimeter
Height6 Centimeter
Outer Diameter10 Centimeter
Width13 Centimeter
Height6 Centimeter
Outer Diameter10 Centimeter
Width13 Centimeter
Height6 Centimeter
Outer Diameter10 Centimeter
Width13 Centimeter
Height6 Centimeter
Outer Diameter10 Centimeter
Width13 Centimeter
Height6 Centimeter
Outer Diameter10 Centimeter
Width13 Centimeter
Height6 Centimeter
Outer Diameter10 Centimeter
Width13 Centimeter
Height6 Centimeter
Outer Diameter10 Centimeter
Width13 Centimeter
Height6 Centimeter
Outer Diameter10 Centimeter
Width13 Centimeter
Height6 Centimeter
Outer Diameter10 Centimeter
Width13 Centimeter
Height6 Centimeter
Outer Diameter10 Centimeter
Width13 Centimeter
Height6 Centimeter
Outer Diameter10 Centimeter
Width13 Centimeter
Height6 Centimeter
Outer Diameter10 Centimeter
Width13 Centimeter
Height6 Centimeter
Outer Diameter10 Centimeter
Width13 Centimeter
Height6 Centimeter
Outer Diameter10 Centimeter
Width13 Centimeter
Height6 Centimeter
Outer Diameter10 Centimeter
Width13 Centimeter
Height6 Centimeter
Outer Diameter10 Centimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *No;
Special Storage Condition, SpecifyBetween 0 and 0 *No;
Special Storage Condition, SpecifyBetween 0 and 0 *No;
Special Storage Condition, SpecifyBetween 0 and 0 *No;
Special Storage Condition, SpecifyBetween 0 and 0 *No;
Special Storage Condition, SpecifyBetween 0 and 0 *No;

Device Identifiers

Device Issuing AgencyDevice ID
GS110884521726604 [Primary]
GS120884521726601 [Package]
Contains: 10884521726604
Package: CASE [3 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FTLMesh, surgical, polymeric

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2022-06-10
Device Publish Date2018-03-12

On-Brand Devices [Duatene]

20884521726632Bilayer Mesh Monofilament Polypropylene
20884521726649Bilayer Mesh Monofilament Polypropylene
20884521726625Bilayer Mesh Monofilament Polypropylene
20884521726618Bilayer Mesh Monofilament Polypropylene
20884521726601Bilayer Mesh Monofilament Polypropylene
20884521726595Bilayer Mesh Monofilament Polypropylene
10884521726581Bilayer Mesh Monofilament Polypropylene
10884521726574Bilayer Mesh Monofilament Polypropylene
10884521726567Bilayer Mesh Monofilament Polypropylene

Trademark Results [Duatene]

Mark Image

Registration | Serial
Company
Trademark
Application Date
DUATENE
DUATENE
87236987 5607617 Live/Registered
Sofradim Production
2016-11-15

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