Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3043337628

FEI Number

3043337628

Entity Name

GOODWILL COMMERCIAL SERVICES

City/State/Country

Indianapolis, IN, US

Establishment Address

6130 E 38th St, Indianapolis, IN 46226, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Goodwill Commercial Services (Owner Number: 10095086)

Owner / Operator Contact Address

6130 East 38th Street, Indianapolis, IN 46226, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Check-Flo Performer Introducer Wittich Nitinol Stone Basket Amplatz Renal Dilator Set Amplatz Radiopaque TFE Sheath Amplatz Renal Introducer Ultraxx Nephrostomy Balloon Set TriForce Peripheral Crossing Set Weinmann - Multi Tracheostomy Exchange Set Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set Amplatz Renal Introducer Amplatz Radiopaque TFE Sheath Amplatz Renal Dilator Set Amplatz Renal Dilator Set with AQ Hydrophilic Coating Micropuncture Check-Flo Performer Introducer Set Performer Balkin Guiding Sheath Check-Flo Performer Introducer Check-Flo Performer Introducer Set Check-Flo Introducer Set Ultraxx Nephrostomy Balloon with TFE Sheath Flexor Check-Flo Introducer Ansel 1 Modification - with High-Flex Dilator and Hydrophilic Coating Flexor Check-Flo Introducer Ansel Modification - with High-Flex Dilator and Hydrophilic Coating Flexor Check-Flo Introducer Raabe Modification Flexor Check-Flo Introducer Ansel Modification Flexor Check-Flo Introducer Set Flexor Ansel Guiding Sheath Flexor Check-Flo Introducer Balkin Up & Over Contralateral Design Ultraxx Nephrostomy Balloon with TFE Sheath Ultraxx Nephrostomy Balloon Set Ciaglia Blue Rhino G2 Advanced Percutaneous Tracheostomy Introducer Set Ciaglia Blue Rhino Percutaneous Tracheostomy Introducer Set

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2026-01-22
FFL	Dislodger, Stone, Basket, Ureteral, Metal	Gastroenterology, Urology	Class 2	876.4680	2026-01-22
LQR	Dislodger, Stone, Biliary	Gastroenterology, Urology	Class 2	876.5010	2026-01-22
KOE	Dilator, Urethral	Gastroenterology, Urology	Class 2	876.5520	2026-01-22
LJE	Catheter, Nephrostomy	Unknown	Class U	N/A	2026-01-22
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2026-01-22
JOH	Tube Tracheostomy And Tube Cuff	Anesthesiology	Class 2	868.5800	2026-01-22
LJE	Catheter, Nephrostomy	Unknown	Class U	N/A	2026-01-22
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2026-01-22
LJE	Catheter, Nephrostomy	Unknown	Class U	N/A	2026-01-22
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2026-01-22
LJE	Catheter, Nephrostomy	Unknown	Class U	N/A	2026-01-22
JOH	Tube Tracheostomy And Tube Cuff	Anesthesiology	Class 2	868.5800	2026-01-22

Official Correspondent

Jerry Clark

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Goodwill Commercial Services

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
K101883	St Jude Medical	6F ENGAGE/ENGAGE TR INTRODUCER	2010-09-07
K034025	Nmt Medical, Inc.	NMT MEDICAL TRANSSEPTAL SHEATH SET, MODELS TSS-10-HSC, TSS-11-HSC, TSS12-HSC	2004-03-26
K122854	Arrow International (Subsidiary of Teleflex Inc.)	ARROW GLIDETHRU PEEL-AWAY SHEATH/DILATOR INTRODUCER	2013-01-04
K233691	Acutus Medical, Inc.	FlexCath Cross Transseptal Solution	2023-12-17
K915078	North American Instrument Corp.	MORSE HEMOSTATIC CATHETER INTRODUCER SET	1992-06-10

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0783-2020	Abbott Medical	2	Fast-Cath Trio HEMOSTASIS INTRODUCER, 14F, 4.6 mm, REF 406303
Z-0789-2020	Abbott Medical	2	Fast-Cath Hemostasis Introducer, HEMOSTASIS INTRODUCER, 8.5F, 2.83 mm, REF 406143 - Product Usage: The Fast-Cath Hemostasis Introducers are indicated for the introduction of angiographic catheters, closed-end catheters, balloon catheters, and electrodes into a vessel where minimizing blood loss is essential.
Z-0044-2017	Teleflex Medical	2	Willy Rusch GmbH Tracheostomy Tube Set Cannulation of tracheotomised patients, particularly in the case of a narrow tracheostoma and narrow-lumen tracheas. When using cannulas with curr. For short term intermittent inflation.

Similar Registrations

Registration Number	Establishment Name	Location
3017689643	CARDIOVIA Ltd.	Nazareth Northern, IL
3041086754	PULNOVO MEDICAL (WUXI) CO., LTD.	Wuxi Jiangsu, CN
3013764800	B. BRAUN MEDICAL INC.	Allentown, PA, US
2020394	BARD PERIPHERAL VASCULAR, INC.	TEMPE, AZ, US
3016904853	SAINT JONES MANAGEMENT LP EOOD	Sofia Sofia-Grad, BG

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3043337628. Last updated year: 2026. Please use registration number 3043337628 when referencing this establishment in official correspondence.