FDA.reportPublic FDA data

Protexter

Primary DI
10813360023407
Brand
Protexter
Company
ICP MEDICAL, LLC
Model
ICP-8150
Catalog number
ICP-8150
Device description
Open Back Gown, SMS, Yellow, Over the Head, Thumb Loop with Elastic Wrist, Universal
Published
2022-11-09
Public version status
New
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
OEANon-Surgical Isolation Gown

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OEANon-Surgical GownGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10813360023407PackageGS110In Commercial Distribution
20813360023404PackageGS110In Commercial Distribution
00813360023400PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081336002340710813360023407
2081336002340420813360023404
00813360023400008133600234008133600234000813360023400

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.

Sterilization Methods#

Method table
Method

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
false
Sterilization required before use
false

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
00813360021475ProtexerICP-Lab CoatsICP-9055LC2025-08-15
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10197106721056CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-15
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10197106833490CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-15
10197106785140CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-13
10197106827802CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-13
10197106829097CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-13
10197106818862CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-05
10197106820759CARDINAL HEALTHCardinal Health 200, LLCOEA2024-10-29
10197106741979CARDINAL HEALTHCardinal Health 200, LLCOEA2024-10-11
10197106472408CARDINAL HEALTHCardinal Health 200, LLCOEA2024-10-07
10197106796115CARDINAL HEALTHCardinal Health 200, LLCOEA2024-10-07
10197106743669CARDINAL HEALTHCardinal Health 200, LLCOEA2024-09-26
10197106744192CARDINAL HEALTHCardinal Health 200, LLCOEA2024-09-26