Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9616765

FEI Number

3002806928

Entity Name

FIRST CARE PRODUCTS LTD.

City/State/Country

Rosh HaAyin Central, IL

Establishment Address

10 Amal St., Afek Industrial Park, Rosh HaAyin Central 4809234, IL

Establishment Type(s)

Repack or Relabel Medical Device,Manufacture Medical Device

Owner / Operator

FIRST CARE PRODUCTS LTD. (Owner Number: 9033111)

Owner / Operator Contact Address

10 Amal St., Afek Industrial Park, Rosh Ha'Ayin, IL-M 4809234, IL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

FCP Bandage Emergency Trauma Dressing Emergency Bandage Wound Stop Tactical Trauma Treatment Bandage Abdominal/Large Wound Area Bandage Emergency Face Shield Emergency Elastic Wrap FCP - GZ series

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GAX	Tourniquet, Nonpneumatic	General, Plastic Surgery	Class 1	878.5900	2008-02-20
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2020-04-16
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2020-08-25
OHO	First Aid Kit Without Drug	General, Plastic Surgery	Class 1	878.4014	2018-07-16

Official Correspondent

No official correspondent registered.

US Agent Details

Kimberly Reed Business: Safeguard US Operating, LLC Email: kimberlyr@safeguardmedical.com Phone: (904) 3223619

Related Public Records

Same Entity

FIRST CARE PRODUCTS LTD.

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9616765. Last updated year: 2026. Please use registration number 9616765 when referencing this establishment in official correspondence.