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Parietex PCO8OSX

by Sofradim Production

Parietex PCO8OSX is a Class II device made by Sofradim Production, listed in FDA GUDID since 6 Oct 2015 (UDI-DI 10884521179721), registry data as of 23 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10884521179721 UDI-DI Date6 Oct 2015ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
Parietex
Generic name
Extra-gynaecological surgical mesh, composite-polymer
Model / reference
PCO8OSX
Primary DI / UDI-DI
10884521179721
FDA product code
FTL
GMDN term
Extra-gynaecological surgical mesh, composite-polymer
Device class
Class II
Regulation number
878.3300
GUDID distribution status
In Commercial Distribution
MRI safety
MR Safe
Size
Outer Diameter — 8 Centimeter

Similar devices in this category

Other devices filed under Extra-gynaecological surgical mesh, composite-polymer.

Other devices from Sofradim Production

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Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (9, all answered No)