FDA.reportPublic FDA data

FCP Bandage

Primary DI
07290017050256
Brand
FCP Bandage
Company
FIRST CARE PRODUCTS LTD
Model
"Gauze 6"""
Catalog number
"Medical Elastic Wrap 6"""
Device description
"Medical Elastic Wrap 6"""
Published
2020-08-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GAXTourniquet, Nonpneumatic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAXTourniquet, NonpneumaticGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290017050256PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290017050256072900170502567290017050256

GMDN Terms#

Term, Definition table
TermDefinition
First aid gauze/bandageA wound cover intended to be used as an initial, short-term treatment after injury. It typically consists of a gauze pad (e.g., cotton wool or lint) that is attached to a roll bandage (e.g., cotton or cotton/viscose). The pad is applied directly to the wound, and the bandage is subsequently wrapped around the pad and secured. The device is intended for use in the home or a clinical setting to protect wounds, arrest bleeding, and introduce medications placed on the pad. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-888-737-7978info@ps-med.com

Regulatory Flags#

DUNS number
514694454
Device count
1
Premarket exempt
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290017050485The Quick-T tourniquetQuick-T2024-10-13
07290017050072FCP BandageFCP072020-08-24
07290017050201FCP BandageT3 Military2020-08-26
07290017050225FCP BandageT6 Military2020-08-26
07290017050249FCP Bandage"Gauze 4"""Medical Elastic Wrap 4’’2020-08-26
07290017050096FCP BandageFCP092020-08-25
07290017050102FCP BandageFCP102020-08-25
07290017050119FCP BandageFCP112020-08-25
07290017050126FCP BandageFCP122020-08-25
07290017050133FCP BandageFCP09+2020-08-25
07290017050140FCP BandageFCP10+2020-08-25
07290017050157FCP BandageWoundStop Care1WS-052020-08-25
07290017050164FCP BandageWoundStop HomeCareWS-042020-08-25
07290017050171FCP BandageFCP10T2020-08-25
07290017050188FCP BandageWoundStop Care1+WS-062020-08-25
07290017050010FCP BandageFCP012020-08-24
07290017050027FCP BandageFCP022020-08-24
07290017050034FCP BandageFCP032020-08-24
07290017050058FCP BandageFCP052020-08-24
07290017050065FCP BandageFCP062020-08-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20888277414249MEDLINEMEDLINE INDUSTRIES, INC.GAX2026-05-20
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40080196774662MEDLINEMEDLINE INDUSTRIES, INC.GAX2026-05-08
40080196781462MEDLINEMEDLINE INDUSTRIES, INC.GAX2026-05-08
20665973032393DukalDukal LLCGAX2025-04-08
20665973032409DukalDukal LLCGAX2025-04-08
20197344105363MEDLINEMEDLINE INDUSTRIES, INC.GAX2025-03-24
30197344006230MEDLINEMEDLINE INDUSTRIES, INC.GAX2025-03-24
00087453143478HysynalHYGENIC CORPORATION, THEGAX2025-03-10
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30382903671985BD Vacutainer® Stretch TourniquetBECTON, DICKINSON AND COMPANYGAX2024-03-13
30382903672098BD Vacutainer® Stretch TourniquetBECTON, DICKINSON AND COMPANYGAX2024-03-13
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