Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1648579

FEI Number

3000205837

Entity Name

Strukmyer Medical

City/State/Country

MESQUITE, TX, US

Establishment Address

1801 Big Town Blvd Ste 100, MESQUITE, TX 75149, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Strukmyer (Owner Number: 10042067)

Owner / Operator Contact Address

1801 Big Town Blvd. Suite 100, Mesquite, TX 75149, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

555

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2023-05-12
KMK	Device, Intravascular Catheter Securement	General Hospital	Class 1	880.5210	2016-08-01
SEJ	Wound Dressings Containing Topical Analgesics	Unknown	Class U	N/A	2021-07-16
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2023-04-13
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2012-10-15
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2018-06-29
CCX	Support, Patient Position	Anesthesiology	Class 1	868.6820	2020-02-06
LFD	Saliva, Artificial	Unknown	Class U	N/A	2021-07-16
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2023-04-13
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2012-10-15
PUI	Drape, Surgical, Exempt	General, Plastic Surgery	Class 2	878.4370	2019-11-04
NAE	Dressing, Wound, Hydrogel Without Drug And/Or Biologic	General, Plastic Surgery	Class 1	878.4022	2012-10-15

Official Correspondent

Sarai Velasco

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Strukmyer

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
K092086	Amerx Health Care Corp.	AMERIGEL WOUND DRESSING PLUS 1/2 OZ. (15G TUBE), MODEL A2025; 1 OZ. (30G TUBE), MODEL A2026; 3 OZ (90G TUBE),MODEL A2027	2009-07-30
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

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
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.
Z-0015-2019	COVIDIEN LLC	1	Kerlix Gauze Roll, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m) Stretched, REF 7880 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.

Similar Registrations

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3043618351	NEORES D.O.O.	Mursko Sredisce Medimurska Zupanija, HR
3007128716	Medline Industries, LP	Norristown, PA, US
3012456427	UFP TECHNOLOGIES, INC.	Newburyport, MA, US
3019843904	OMEZA, LLC	Sarasota, FL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1648579. Last updated year: 2026. Please use registration number 1648579 when referencing this establishment in official correspondence.