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Panels › General Hospital › Product code NEC · Class 1

Bandage, Liquid, Skin Protectant

Regulation 880.5090

0510(k)s in 12 months (3 all time)

0recalls in 12 months (6 all time)

0recalls that name a 510(k)

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Top companies in NEC

Company	510(k)s	Recalls
BioDerm, Inc.	0	3
Aplicare, Inc.	2	0
MEDLINE INDUSTRIES INC	0	1
Medlogic Global Corp.	1	0
Safe N Simple, LLC	0	1
Smith & Nephew Inc.	0	1

Date	Firm and product	Code	Linked 510(k)
Aug 30, 2018	MEDLINE INDUSTRIES INC Unna-Z: Unna Boot Compression Wrap with Zinc Oxide and Calamine, Item Numbers: a) NONUNNA3 and b) NONUNNA4 Product is packaged in a foil pouch, which is inserted in a box carton. There are 12 carto Terminated	NEC	None listed
Jun 10, 2014	BioDerm, Inc. BioDerm Safe n' Dry 21006 (Component: SKIN-PREP Protective wipes). The recalled wipes are used on intact skin for applying skin protectant to the glands for control of male incontinence with an exter Terminated	NEC	None listed
Jun 10, 2014	BioDerm, Inc. BioDerm Liberty Pouch Clean & Dry External Male Catheter Specialty Type with integral collection chamber (Component: SKIN-PREP Protective wipes). The recalled wipes are used on intact skin for apply Terminated	NEC	None listed
Jun 10, 2014	BioDerm, Inc. BioDerm Liberty 3.0 External Male Catheter Specialty Type with integral collection chamber (Component: SKIN-PREP Protective wipes). The recalled wipes are used on intact skin for applying skin prote Terminated	NEC	None listed
Jun 18, 2012	Safe N Simple, LLC Safe N Simple No-Sting Skin Barrier Film, Ostomy Skin Barrier Wipe, SNS00807 Terminated	NEC	None listed
Jul 6, 2011	Smith & Nephew Inc. BRAND: SKIN-PREP - Pouch Labeling and Box / Carton Labeling *smith&nephew #420400**SKIN-PREP Protective Wipes Effective protection between tape and skin Reduces risk of tape stripping H Terminated	NEC	None listed

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