Duatene

GUDID 10884521726581

Bilayer Mesh Monofilament Polypropylene

SOFRADIM PRODUCTION

Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable

Primary Device ID	10884521726581
NIH Device Record Key	151b16da-06d6-4fe5-b972-deab171c793f
Commercial Distribution Status	In Commercial Distribution
Brand Name	Duatene
Version Model Number	DTN1610E
Company DUNS	576342646
Company Name	SOFRADIM PRODUCTION
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	MR Safe
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

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

Device Dimensions

Device Size Text, specify	0
Height	6 Centimeter
Width	13 Centimeter
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Height	6 Centimeter
Width	13 Centimeter
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Height	6 Centimeter
Width	13 Centimeter
Device Size Text, specify	0
Height	6 Centimeter
Width	13 Centimeter
Device Size Text, specify	0
Height	6 Centimeter
Width	13 Centimeter
Device Size Text, specify	0
Height	6 Centimeter
Width	13 Centimeter
Device Size Text, specify	0
Height	6 Centimeter
Width	13 Centimeter
Device Size Text, specify	0
Height	6 Centimeter
Width	13 Centimeter
Device Size Text, specify	0
Height	6 Centimeter
Width	13 Centimeter
Device Size Text, specify	0
Height	6 Centimeter
Width	13 Centimeter
Device Size Text, specify	0
Height	6 Centimeter
Width	13 Centimeter
Device Size Text, specify	0
Height	6 Centimeter
Width	13 Centimeter
Device Size Text, specify	0
Height	6 Centimeter
Width	13 Centimeter
Device Size Text, specify	0
Height	6 Centimeter
Width	13 Centimeter
Device Size Text, specify	0
Height	6 Centimeter
Width	13 Centimeter
Device Size Text, specify	0
Height	6 Centimeter
Width	13 Centimeter
Device Size Text, specify	0
Height	6 Centimeter
Width	13 Centimeter
Device Size Text, specify	0
Height	6 Centimeter
Width	13 Centimeter
Device Size Text, specify	0
Height	6 Centimeter
Width	13 Centimeter
Device Size Text, specify	0
Height	6 Centimeter
Width	13 Centimeter
Device Size Text, specify	0
Height	6 Centimeter
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Height	6 Centimeter
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Device Size Text, specify	0
Height	6 Centimeter
Width	13 Centimeter
Device Size Text, specify	0
Height	6 Centimeter
Width	13 Centimeter
Device Size Text, specify	0
Height	6 Centimeter
Width	13 Centimeter
Device Size Text, specify	0
Height	6 Centimeter
Width	13 Centimeter
Device Size Text, specify	0
Height	6 Centimeter
Width	13 Centimeter
Device Size Text, specify	0
Height	6 Centimeter
Width	13 Centimeter
Device Size Text, specify	0
Height	6 Centimeter
Width	13 Centimeter
Device Size Text, specify	0
Height	6 Centimeter
Width	13 Centimeter
Device Size Text, specify	0
Height	6 Centimeter
Width	13 Centimeter
Device Size Text, specify	0
Height	6 Centimeter
Width	13 Centimeter
Device Size Text, specify	0
Height	6 Centimeter
Width	13 Centimeter
Device Size Text, specify	0
Height	6 Centimeter
Width	13 Centimeter
Device Size Text, specify	0
Height	6 Centimeter
Width	13 Centimeter
Device Size Text, specify	0
Height	6 Centimeter
Width	13 Centimeter
Device Size Text, specify	0
Height	6 Centimeter
Width	13 Centimeter
Device Size Text, specify	0
Height	6 Centimeter
Width	13 Centimeter
Device Size Text, specify	0
Height	6 Centimeter
Width	13 Centimeter
Device Size Text, specify	0
Height	6 Centimeter
Width	13 Centimeter
Device Size Text, specify	0
Height	6 Centimeter
Width	13 Centimeter
Device Size Text, specify	0
Height	6 Centimeter
Width	13 Centimeter
Device Size Text, specify	0
Height	6 Centimeter
Width	13 Centimeter
Device Size Text, specify	0
Height	6 Centimeter
Width	13 Centimeter
Device Size Text, specify	0
Height	6 Centimeter
Width	13 Centimeter
Device Size Text, specify	0
Height	6 Centimeter
Width	13 Centimeter
Device Size Text, specify	0
Height	6 Centimeter
Width	13 Centimeter
Device Size Text, specify	0
Height	6 Centimeter
Width	13 Centimeter
Device Size Text, specify	0
Height	6 Centimeter
Width	13 Centimeter
Device Size Text, specify	0
Height	6 Centimeter
Width	13 Centimeter
Device Size Text, specify	0
Height	6 Centimeter
Width	13 Centimeter
Device Size Text, specify	0
Height	6 Centimeter
Width	13 Centimeter
Device Size Text, specify	0
Height	6 Centimeter
Width	13 Centimeter
Device Size Text, specify	0
Height	6 Centimeter
Width	13 Centimeter
Device Size Text, specify	0
Height	6 Centimeter
Width	13 Centimeter
Device Size Text, specify	0
Height	6 Centimeter
Width	13 Centimeter
Device Size Text, specify	0
Height	6 Centimeter
Width	13 Centimeter
Device Size Text, specify	0
Height	6 Centimeter
Width	13 Centimeter
Device Size Text, specify	0
Height	6 Centimeter
Width	13 Centimeter
Device Size Text, specify	0
Height	6 Centimeter
Width	13 Centimeter
Device Size Text, specify	0
Height	6 Centimeter
Width	13 Centimeter
Device Size Text, specify	0
Height	6 Centimeter
Width	13 Centimeter
Device Size Text, specify	0
Height	6 Centimeter
Width	13 Centimeter
Device Size Text, specify	0
Height	6 Centimeter
Width	13 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	10884521726581 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K172395

FDA Product Code

FTL	Mesh, surgical, polymeric

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	6
Public Version Date	2022-06-10
Device Publish Date	2018-03-12

On-Brand Devices [Duatene]

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

Trademark Results [Duatene]

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