FDA.reportPublic FDA data

Protexer

Primary DI
00813360021475
Brand
Protexer
Company
ICP MEDICAL, LLC
Model
ICP-Lab Coats
Catalog number
ICP-9055LC
Device description
Lab Coat, Blue, Traditional Collar, Knit Cuffs, Snap Front, 3 pockets, 2XL
Published
2025-08-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
FYCGown, Isolation, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FYCGown, Isolation, SurgicalGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10813360021472PackageGS125In Commercial Distribution
20813360021479PackageGS12In Commercial Distribution
00813360021475PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081336002147210813360021472
2081336002147920813360021479
00813360021475008133600214758133600214750813360021475

GMDN Terms#

Term, Definition table
TermDefinition
Isolation gown, single-useA garment made of natural and/or synthetic materials intended to be worn by healthcare providers or visitors to isolate themselves from patients. The isolation gown helps to protect the patient (e.g., burn patients) from the transfer of infectious agents carried by the healthcare provider or visitor; or it may help to protect the healthcare provider or visitor from a contagious agent which has infected the patient. This is a single-use garment.

Regulatory Flags#

DUNS number
078780963
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00688162000665ProtexerPR-Shoe CoversPR-SCGT012026-04-27
00688162000672ProtexerPR-Shoe CoversPR-SCGT022026-04-27
00688162000023ProtexerICP-SCNSICP-SCNS00012025-08-19
00813360021512ProtexerPR-BCBPR-BCB5002025-08-19
00813360021789ProtexerICP-SCNSICP-SCNS00032025-08-19
00813360021796ProtexerICP-SCXTICP-SCXT00022025-08-19
10688162000020ProtexerICP-SCNSICP-SCNS00012025-08-19
10813360021519ProtexerPR-BCBPR-BCB5002025-08-19
10813360021786ProtexerICP-SCNSICP-SCNS00032025-08-19
10813360021793ProtexerICP-SCXTICP-SCXT00022025-08-19
10813360021472ProtexerICP-Lab CoatsICP-9055LC2025-08-15
00688162000047ProtexerICP-BCNCICP-BCNC00032022-10-31
00688162000511Protexter1ICP-8150FC-2XL2025-08-12
00688162381504ProtexerICP-BCNSICP-BCNS00022022-10-31
10688162000518Protexter1ICP-8150FC-2XL2025-08-12
00688162384512ProtexerICP-CP23ICP-CP232023-06-06
00813360021468ProtexerICP-Lab CoatsICP-9054LC2025-08-08
00688162000030ProtexerICP-ScrubsICP-9000BTM2025-08-08
00688162290004ProtexerICP-ScrubsICP-9000TOP2025-08-08
00688162390506ProtexerICP-ScrubsICP-9050TOP2025-08-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10813360021472ProtexerICP MEDICAL, LLCFYC2025-08-15
00813360021468ProtexerICP MEDICAL, LLCFYC2025-08-08
00688162000030ProtexerICP MEDICAL, LLCFYC2025-08-08
00688162290004ProtexerICP MEDICAL, LLCFYC2025-08-08
00688162390506ProtexerICP MEDICAL, LLCFYC2025-08-08
10813360021465ProtexerICP MEDICAL, LLCFYC2025-08-08
00813360021772ProtexerICP MEDICAL, LLCFYC2025-08-08
00842942015175PRIMEDpriMED Medical Products IncFYC2025-07-21
00842942015304PRIMEDpriMED Medical Products IncFYC2025-07-21
10842942015172PRIMEDpriMED Medical Products IncFYC2025-07-21
10842942015301PRIMEDpriMED Medical Products IncFYC2025-07-21
04719882251399CopioumedCOPIOUMED INTERNATIONAL INC.FYC2025-07-16
04719882251412CopioumedCOPIOUMED INTERNATIONAL INC.FYC2025-07-16
04719882251436CopioumedCOPIOUMED INTERNATIONAL INC.FYC2025-07-16
04719882251450CopioumedCOPIOUMED INTERNATIONAL INC.FYC2025-07-16
04719882251559CopioumedCOPIOUMED INTERNATIONAL INC.FYC2025-07-16
04719882251573CopioumedCOPIOUMED INTERNATIONAL INC.FYC2025-07-16
04719882251597CopioumedCOPIOUMED INTERNATIONAL INC.FYC2025-07-16
04719882251610CopioumedCOPIOUMED INTERNATIONAL INC.FYC2025-07-16
04719882251719CopioumedCOPIOUMED INTERNATIONAL INC.FYC2025-07-16
04719882251733CopioumedCOPIOUMED INTERNATIONAL INC.FYC2025-07-16
04719882251757CopioumedCOPIOUMED INTERNATIONAL INC.FYC2025-07-16
04719882251771CopioumedCOPIOUMED INTERNATIONAL INC.FYC2025-07-16
14719882251396CopioumedCOPIOUMED INTERNATIONAL INC.FYC2025-07-16
14719882251419CopioumedCOPIOUMED INTERNATIONAL INC.FYC2025-07-16
14719882251433CopioumedCOPIOUMED INTERNATIONAL INC.FYC2025-07-16
14719882251457CopioumedCOPIOUMED INTERNATIONAL INC.FYC2025-07-16
14719882251556CopioumedCOPIOUMED INTERNATIONAL INC.FYC2025-07-16
14719882251570CopioumedCOPIOUMED INTERNATIONAL INC.FYC2025-07-16
14719882251594CopioumedCOPIOUMED INTERNATIONAL INC.FYC2025-07-16