Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007417132

FEI Number

3007417132

Entity Name

THE HIBBERT GROUP - WDC Delaware

City/State/Country

New Castle, DE, US

Establishment Address

890 Ships Landing Way, New Castle, DE 19720, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

The Hibbert Group (Owner Number: 10028889)

Owner / Operator Contact Address

400 Pennington Ave, Trenton, NJ 08618, 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
EXD	Irrigator, Ostomy	Gastroenterology, Urology	Class 2	876.5895	2020-12-02
EZR	Cement, Stomal Appliance, Ostomy	Gastroenterology, Urology	Class 1	876.5900	2020-12-02
EXH	Bag, Urinary, Ileostomy	Gastroenterology, Urology	Class 1	876.5900	2020-12-02
EXA	Selector, Size, Ostomy	Gastroenterology, Urology	Class 1	876.5900	2020-12-02
EXB	Collector, Ostomy	Gastroenterology, Urology	Class 1	876.5900	2020-12-02
EXE	Protector, Ostomy	Gastroenterology, Urology	Class 1	876.5900	2020-12-02
GAA	Needle, Aspiration And Injection, Disposable	General, Plastic Surgery	Class 1	878.4800	2009-03-17
EXG	Bag, Urine Collecting, Ureterostomy	Gastroenterology, Urology	Class 1	876.5900	2020-12-02
FON	Bag, Drainage, With Adhesive, Ostomy	Gastroenterology, Urology	Class 1	876.5900	2020-12-02
EZQ	Pouch, Colostomy	Gastroenterology, Urology	Class 1	876.5900	2020-12-02
EZP	Rod, Colostomy	Gastroenterology, Urology	Class 2	876.4270	2020-12-02
EZS	Appliance, Colostomy, Disposable	Gastroenterology, Urology	Class 1	876.5900	2020-12-02

Official Correspondent

Michelle Bradley

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

The Hibbert Group

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3005676736	THE HIBBERT GROUP - WDC NJ	Trenton, NJ, US
3007527549	The Hibbert Group	Aurora, CO, US
3001728571	THE HIBBERT GROUP - Corp Center	Hamilton, NJ, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K781371	Ferris Mfg. Corp.	BONE MARROW ASPIRATION KIT	1978-09-20

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-0017-2023	Hobbs Medical, Inc.	1	Hobbs Transbronchial Aspiration Needle and Vacu-lok Aspirating Syringe Catalog Number: 4620
Z-0018-2023	Hobbs Medical, Inc.	1	Hobbs Transbronchial Aspiration Needle Catalog Number: 4621
Z-0023-2011	Becton Dickinson & Company	1	BD 30G1/2 PrecisionGlide Needle;Catalog/Lot Number: 305106. Needles are intended for use in aspiration and injection of medications.

Similar Registrations

Registration Number	Establishment Name	Location
3008806809	ConvaTec Limited, GDC Building	Deeside Flintshire, GB
1526012	APPLIED MEDICAL TECHNOLOGY, INC.	Brecksville, OH, US
1480288	HOLLISTER INCORPORATED	LIBERTYVILLE, IL, US
3031233007	BMMEDICAL	Lelystad Flevoland, NL
9618003	CONVATEC DOMINICAN REPUBLIC, INC.	Haina San Cristobal, DO

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007417132. Last updated year: 2026. Please use registration number 3007417132 when referencing this establishment in official correspondence.