Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8021832

FEI Number

3004545959

Entity Name

IVOR SHAW, LTD.

City/State/Country

DERBY, GB

Establishment Address

CITY GATE, LONDON ROAD, DERBY DE 24 8WY, GB

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

IVOR SHAW, LTD. TRADING AS PENNINE HEALTHCARE (Owner Number: 8021832)

Owner / Operator Contact Address

CITY GATE, LONDON ROAD, DERBY, GB-NOTA DE 24 8WY, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

EasyFlow CELOX Gauze CELOX EMS CELOX RAPID Gauze

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JOL	Catheter And Tip, Suction	General Hospital	Class 2	880.6740	1984-10-24
QSY	Hemostatic Wound Dressing Without Thrombin Or Other Biologics	Unknown	Class U	N/A	2023-10-25
QSY	Hemostatic Wound Dressing Without Thrombin Or Other Biologics	Unknown	Class U	N/A	2023-10-25

Official Correspondent

No official correspondent registered.

US Agent Details

John Lockwood Business: Polaris Compliance Consulting, LLC Email: jlqrconsulting@outlook.com Phone: (317) 4307846

Related Public Records

Same Entity

IVOR SHAW, LTD. TRADING AS PENNINE HEALTHCARE

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
K220566	Koag, LLC	Vascette HP (hemostatic pad)	2022-07-29
K080818	Hem Con Medical Technologies, Inc.	HEMCON BANDAGE, HEMCON BANDAGE OTC, HEMCON CHITOFLEX-SURGICAL DRESSING	2008-05-15
K893123	Les Laboratorires Brothier, S.A.	ADHESIVE BANDAGES & PADS FOR MINOR CUTS/SCRAPES	1990-02-13
K143462	Benq Materials Corporation	AnsCare ChitoClot Gauze (prescription use), AnsCare ChitoClot Gauze (over-the-counter use)	2015-05-08
K040208	Tz Medical, Inc.	NEPTUNE PAD, NEPTUNE DISC, NEPTUNE COMFORT-BAND, COMFORT-BAND	2004-05-11

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0007-2013	Invuity, Inc.	2	BriteField illuminated Suction Device; Model numbers 8Fr, 10Fr and 12Fr, Kit (included 8Fr, 10Fr and 12Fr and a sterilization tray. The Invuity Brite Field Illuminated Suction Device is intended to aspirate from the surgical site and to provide illumination from a high intensity light source.

Similar Registrations

Registration Number	Establishment Name	Location
3007477849	PATIENT SHIELD CONCEPTS LLC	Denver, CO, US
3019385708	OBP SURGICAL CORPORATION	Lawrence, MA, US
3025831202	TKR HUANAN ELECTRONICS (DONGGUAN) CO., LTD.	Dongguan City Guangdong, CN
3027150141	SWIFTSURE INNOVATIONS INC.	Pasadena Newfoundland and Labrador, CA
3015337348	Primecare Medical (Suzhou) Co.,Ltd.	Changshu Jiangsu, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8021832. Last updated year: 2026. Please use registration number 8021832 when referencing this establishment in official correspondence.