Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008374791

FEI Number

3008374791

Entity Name

SAFE N SIMPLE LLC

City/State/Country

Clarkston, MI, US

Establishment Address

5827 Terex, Clarkston, MI 48346, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Safe N Simple LLC (Owner Number: 10033201)

Owner / Operator Contact Address

8112 Rosebud Lane, Clarkston, MI 48348, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2018-05-31
EXN	Support, Hernia	Gastroenterology, Urology	Class 1	876.5970	2018-05-31
NAE	Dressing, Wound, Hydrogel Without Drug And/Or Biologic	General, Plastic Surgery	Class 1	878.4022	2018-05-31
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2019-11-05
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2024-11-21
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2021-09-23
EZR	Cement, Stomal Appliance, Ostomy	Gastroenterology, Urology	Class 1	876.5900	2012-12-04
KGN	Wound Dressing With Animal-Derived Material(S)	Unknown	Class U	N/A	2013-11-12
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2017-04-24
EZS	Appliance, Colostomy, Disposable	Gastroenterology, Urology	Class 1	876.5900	2012-12-04
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2014-01-16
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2018-05-31
NEC	Bandage, Liquid, Skin Protectant	General Hospital	Class 1	880.5090	2012-12-04
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2017-04-24
KGN	Wound Dressing With Animal-Derived Material(S)	Unknown	Class U	N/A	2014-05-14
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2024-11-21
KOX	Solvent, Adhesive Tape	General, Plastic Surgery	Class 1	878.4730	2012-12-04

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Safe N Simple LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K843874	Beiersdorf, Inc.	LEUKOPOR SURGICAL TAPE	1985-02-21
K915446	Sun Glitz Corp.	STRETCH WRAP	1992-05-06
K833120	Acme United Corp.	ONE TIME COMPOUND BENZOIN TINCTURE-	1983-12-29
K870091	Avery Intl.	IV SECUREMENT DEVICE USING PCCE THERMO. FILM	1987-02-04
K150256	Argentum Medical	SILVERLON BURN CONTACT DRESSINGS	2015-04-30

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-06	B. Braun Medical, Inc.	U	D-Stat Dry Hemostatic Bandage. The product is an adhesive bandage.
Z-0038-2025	3M Company Health Care Business 3m Center	U	3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R

Similar Registrations

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3014553350	CORRECT BREATHING CONCEPTS, LLC	Painesville, OH, US
3023122974	MBET HEALTH, LLC	Tarzana, CA, US
3012453673	FANNIN (UK) LIMITED	Measham, Swadlincote Derbyshire, GB
3019843433	The Natural Patch Company Pty Ltd	Prahran Victoria, AU

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008374791. Last updated year: 2026. Please use registration number 3008374791 when referencing this establishment in official correspondence.