Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009167225

FEI Number

3009167225

Entity Name

SARASOTA MEDICAL PRODUCTS

City/State/Country

Sarasota, FL, US

Establishment Address

1451 Sarasota Center Blvd, Sarasota, FL 34240, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Sarasota Medical Products (Owner Number: 10041215)

Owner / Operator Contact Address

1451 Sarasota Center Blvd, Sarasota, FL 34240, 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
EXB	Collector, Ostomy	Gastroenterology, Urology	Class 1	876.5900	2015-03-20
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2015-12-23
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2014-12-04
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2013-03-01
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2013-03-01
EZS	Appliance, Colostomy, Disposable	Gastroenterology, Urology	Class 1	876.5900	2012-07-02
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2024-04-30
KOX	Solvent, Adhesive Tape	General, Plastic Surgery	Class 1	878.4730	2021-02-17
NAE	Dressing, Wound, Hydrogel Without Drug And/Or Biologic	General, Plastic Surgery	Class 1	878.4022	2014-12-04

Official Correspondent

Walt Leise

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Sarasota Medical Products

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
K150256	Argentum Medical	SILVERLON BURN CONTACT DRESSINGS	2015-04-30
K881936	Iberhospitex, S.A.	OPER-FILM-ADHESIVE MEMBRANE	1988-08-31
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

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0013-2012	Convatec Inc.	1	Natura Durahesive ConvaTec Moldable Technology Post-Operative /Surgical System (57 mm) Required for application to a patient immediately after ostomy surgery.
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
Z-0013-2019	COVIDIEN LLC	1	Kerlix AMD Antimicrobial Bandage Roll, 6 Ply, 4-1/2 x 12.3 (11.4 cm x 3.7m), REF 3332 Product Usage- as both primary and secondary dressing containing PHMB (polyhexamethylene biguanide) to resist bacterial colonization within the dressing and bacterial penetration through the dressing.
Z-0014-2019	COVIDIEN LLC	1	Kerlix Bandage Roll, 100% Cotton, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m), REF 6715 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.

Similar Registrations

Registration Number	Establishment Name	Location
1513988	KUTOL PRODUCTS COMPANY	Sharonville, OH, US
3006131984	SEISA MEDICAL INC	El Paso, TX, US
3004111573	Sterigenics US LLC	Grand Prairie, TX, US
3011707784	CHANGSHU ROZER STERILIZATION TECHNOLOGY CO., LTD.	Changshu Jiangsu, CN
3008244559	CASEX, LTDA	Curitiba Parana, BR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009167225. Last updated year: 2026. Please use registration number 3009167225 when referencing this establishment in official correspondence.