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Duatene

FDA UDI

Class II (US FDA UDI)

by Sofradim Production

Identity

Trade Name
Duatene FDA UDI
Generic Name
Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable FDA UDI
Device Name
Bilayer Mesh Monofilament Polypropylene FDA UDI
Model / Reference
DTN07RX3 FDA UDI
Description
Bilayer Mesh Monofilament Polypropylene FDA UDI

Identifiers

Primary DI / UDI-DI
10884521726598 FDA UDI
510(k) Number
K172395 FDA UDI
FDA Product Code
FTL FDA UDI
GMDN Term
Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.3300 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Safe FDA UDI

Dimensions & Sizes

Size
Outer Diameter — 7 Centimeter FDA UDI
Height — 4.5 Centimeter FDA UDI
Width — 10 Centimeter FDA UDI

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

Duatene by Sofradim Production — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Sofradim Production

Sources (1)

  • FDA UDI e2afc805-eb89-4a42-8b15-dc888335f70b 36 fields · synced Jun 6, 2026