Permacol P100055

• FDA 510(k) K120605 decided 18 May 2012 Active
• FDA GUDID UDI-DI 10884523000047 listed 16 Oct 2015 Listed

1. 18 May 2012 Cleared FDA 510(k) K120605
2. 16 Oct 2015 Listed FDA GUDID 10884523000047

Trade name

Permacol

Generic name

Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial

Model / reference

P100055

Primary DI / UDI-DI

10884523000047

510(k) Number

K120605 ↗

FDA product code

FTM

GMDN term

Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial

Device class

Class II

Regulation number

878.3300

GUDID distribution status

In Commercial Distribution

Size

Width — 5 Centimeter

Depth — 1 Millimeter

Length — 5 Centimeter

Category: Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial

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See all devices from Sofradim Production →