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Parietex

FDA UDI

Class II (US FDA UDI)

by Sofradim Production

Identity

Trade Name
Parietex FDA UDI
Generic Name
Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable FDA UDI
Device Name
Hydrophilic Anatomical Mesh, Left Side, Polyester FDA UDI
Model / Reference
TECR1510AL FDA UDI
Description
Hydrophilic Anatomical Mesh, Left Side, Polyester FDA UDI

Identifiers

Catalog Number
TECR1510AL FDA UDI
Primary DI / UDI-DI
10884521180192 FDA UDI
510(k) Number
K982532 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
Not 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

Dimensions & Sizes

Size
Length — 15 Centimeter FDA UDI

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

Cleared under the same submission

K982532 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Sofradim Production

Sources (1)

  • FDA UDI 1330730f-2efd-4015-9c6c-5dab938ec751 38 fields · synced May 31, 2026