FDA.reportPublic FDA data

Protexer

Primary DI
00688162290004
Brand
Protexer
Company
ICP MEDICAL, LLC
Model
ICP-Scrubs
Catalog number
ICP-9000TOP
Device description
Scrub Top, SMS, Blue, V-Neck, Large
Published
2025-08-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
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
10688162290001PackageGS125In Commercial Distribution
20688162290008PackageGS14In Commercial Distribution
00688162290004PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1068816229000110688162290001
2068816229000820688162290008
00688162290004006881622900046881622900040688162290004

GMDN Terms#

Term, Definition table
TermDefinition
Scrub suit, single-useA two-piece garment designed to be worn by healthcare staff to facilitate hygienic conditions typically in areas where surgery is performed. It typically consists of a shirt and pants composed of disposable materials and is intended to provide a barrier to help prevent cross-contamination of infectious agents between staff and patients. This is a single-use garment.

Regulatory Flags#

DUNS number
078780963
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00688162000764Protexter1ICP-83502026-08-05
00688162000023ProtexerICP-SCNSICP-SCNS00012025-08-19
00688162000047ProtexerICP-BCNCICP-BCNC00032022-10-31
00688162000054ProtexerICP-CPPSB 21"ICP-CPPSB00212022-10-31
00688162000467ICP2ICP-9001GUR2023-10-05
00688162000511Protexter1ICP-8150FC-2XL2025-08-12
00688162000665ProtexerPR-Shoe CoversPR-SCGT012026-04-27
00688162000672ProtexerPR-Shoe CoversPR-SCGT022026-04-27
00688162124002ProtexerICP-CPXP 24ICP-CPXP242022-10-31
00688162381504ProtexerICP-BCNSICP-BCNS00022022-10-31
00688162400007ProtexerICP-CPPSB 24"ICP-CPPSB00242022-10-31
00688162800005ProtexerICP-CPPSB 28"ICP-CPPSB00282022-10-31
00813360021369ProtexerICP-8200ICP-82002022-01-17
00813360021376ProtexerICP-8250ICP-82502022-01-17
00813360021390ProtexerICP-3845ICP-38452022-02-03
00813360021468ProtexerICP-Lab CoatsICP-9054LC2025-08-08
00813360021475ProtexerICP-Lab CoatsICP-9055LC2025-08-15
00813360021505Protexter181502020-07-09
00813360021512ProtexerPR-BCBPR-BCB5002025-08-19
00813360021543ProtexerICP-5050YFCICP-5050YFC2022-10-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00813360021475ProtexerICP MEDICAL, LLCFYC2025-08-15
10813360021472ProtexerICP MEDICAL, LLCFYC2025-08-15
00813360021468ProtexerICP MEDICAL, LLCFYC2025-08-08
00688162000030ProtexerICP 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