Dextile DXT1309AL

GUDID 10884521726505

Anatomical Mesh Pre-shaped Monofilament Polypropylene Textile with Marking;Left Side

SOFRADIM PRODUCTION

Abdominal hernia surgical mesh, synthetic polymer, non-bioabsorbable
Primary Device ID10884521726505
NIH Device Record Key9c313137-52a0-4a5b-8012-ab3db7e484f0
Commercial Distribution StatusIn Commercial Distribution
Brand NameDextile
Version Model NumberDXT1309AL
Catalog NumberDXT1309AL
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
Device Size Text, specify0
Length9 Centimeter
Width13 Centimeter
Device Size Text, specify0
Length9 Centimeter
Width13 Centimeter
Device Size Text, specify0
Length9 Centimeter
Width13 Centimeter
Device Size Text, specify0
Length9 Centimeter
Width13 Centimeter
Device Size Text, specify0
Length9 Centimeter
Width13 Centimeter
Device Size Text, specify0
Length9 Centimeter
Width13 Centimeter
Length9 Centimeter
Width13 Centimeter
Length9 Centimeter
Width13 Centimeter
Length9 Centimeter
Width13 Centimeter
Length9 Centimeter
Width13 Centimeter
Length9 Centimeter
Width13 Centimeter
Length9 Centimeter
Width13 Centimeter
Length9 Centimeter
Width13 Centimeter
Length9 Centimeter
Width13 Centimeter
Length9 Centimeter
Width13 Centimeter
Length9 Centimeter
Width13 Centimeter
Length9 Centimeter
Width13 Centimeter
Length9 Centimeter
Width13 Centimeter
Length9 Centimeter
Width13 Centimeter
Length9 Centimeter
Width13 Centimeter
Length9 Centimeter
Width13 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;
Special Storage Condition, SpecifyBetween 0 and 0 *No;

Device Identifiers

Device Issuing AgencyDevice ID
GS110884521726505 [Primary]

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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-01-20
Device Publish Date2020-01-10

On-Brand Devices [Dextile]

10884521726543Anatomical Mesh Pre-shaped Monofilament Polypropylene Textile with Marking;Left Side
10884521726536Anatomical Mesh Pre-shaped Monofilament Polypropylene Textile with Marking;Right Side
10884521726529Anatomical Mesh Pre-shaped Monofilament Polypropylene Textile with Marking;Left Side
10884521726512Anatomical Mesh Pre-shaped Monofilament Polypropylene Textile with Marking;Right Side
10884521726505Anatomical Mesh Pre-shaped Monofilament Polypropylene Textile with Marking;Left Side
10884521726499Anatomical Mesh Pre-shaped Monofilament Polypropylene Textile with Marking;Right Side

Trademark Results [Dextile]

Mark Image

Registration | Serial
Company
Trademark
Application Date
DEXTILE
DEXTILE
88722711 not registered Live/Pending
Sofradim Production
2019-12-11
DEXTILE
DEXTILE
87249164 not registered Live/Pending
Sofradim Production
2016-11-28

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