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Parietene PPM1106X3

by Sofradim Production

Parietene PPM1106X3 is a Class II device made by Sofradim Production, cleared under FDA 510(k) K223218 on 2 Dec 2022 (1 earlier submission) and listed in FDA GUDID since 16 Apr 2016 (UDI-DI 10884521213807), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK223218 Date2 Dec 2022DecidedStatusActive
United StatesGUDID listing Number10884521213807 UDI-DI Date16 Apr 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • FDA 510(k) K223218 decided 2 Dec 2022 Active· +1 more in the status table
  • FDA GUDID UDI-DI 10884521213807 listed 16 Apr 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K142091
  2. Listed FDA GUDID 10884521213807
  3. Cleared FDA 510(k) K223218

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Parietene
Generic name
Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable
Model / reference
PPM1106X3
Primary DI / UDI-DI
10884521213807
510(k) Number
FDA product code
FTL
GMDN term
Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable
Device class
Class II
Regulation number
878.3300
GUDID distribution status
In Commercial Distribution
Size
Length — 11 Centimeter
Width — 6 Centimeter

Related devices

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

Cleared under the same submission (K142091)

and 8 more cleared under K142091

Cleared under the same submission (K223218)

and 8 more cleared under K223218

Similar devices in this category

Other devices filed under Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable.

Other devices from Sofradim Production

See all devices from Sofradim Production →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (8, all answered No)