FDA.reportPublic FDA data

ProCure

Primary DI
10840330704882
Brand
ProCure
Company
Twin Med, LLC
Model
PCFS200
Catalog number
PCFS200
Device description
Safety Face Shield Visor Protective Mask w/Headstrap Universal size 200/cs
Published
2026-05-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LYUAccessory, Surgical Apparel

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LYUAccessory, Surgical ApparelGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30840330704886PackageGS1200In Commercial Distribution
10840330704882PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3084033070488630840330704886
1084033070488210840330704882

GMDN Terms#

Term, Definition table
TermDefinition
Face splash shield, single-useA clear, transparent guard intended to provide full face cover, to protect (shield) the healthcare worker from blood and other body fluid splashes while performing a clinical or laboratory procedure. It is commonly known as a splash shield. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
804-776-2877xx@xx.xx

Regulatory Flags#

DUNS number
107071289
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10840330705599ProCurePCSDPN500PCSDPN5002026-05-12
10840330706695ProCurePCHF3005PCHF30052026-05-07
10840330706701ProCurePCHF3006PCHF30062026-05-07
10840330702574ProCurePCGBMB60PPCGBMB60P2026-05-06
10840330702581ProCurePCGBMB60WPCGBMB60W2026-05-06
10840330702598ProCurePCGBMB72PPCGBMB72P2026-05-06
10840330702604ProCurePCGBPB72PPCGBPB72P2026-05-06
10840330702291ProCurePC136PC1362026-05-05
10840330702307ProCurePC137PC1372026-05-05
10840330702314ProCurePC138PC1382026-05-05
10840330704363ProCurePC167PC1672026-05-05
10840330706558ProCurePCDT60PCDT602026-05-05
10840330706565ProCurePCIT01PCIT012026-05-05
10840330706596ProCurePC631PC6312026-05-05
10840330706671ProCurePC601PC6012026-05-05
10840330705858ProCurePCHC10044PCHC100442026-05-04
10840330706688ProCurePCHSWG15PCHSWG152026-05-04
10840330701560ProCurePCHTF45PCHTF452026-04-28
10840330701577ProCurePCHTF611PCHTF6112026-04-28
10840330701584ProCurePCHTD23PCHTD232026-04-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10097604245002Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2024-08-12
10097604245057Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2024-08-12
10097604245101Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2024-08-12
10097604245200Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2024-08-12
10097604245309Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2024-08-12
10097604245354Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2024-08-12
10097604245408Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2024-08-12
10097604245453Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2024-08-12
10097604245507Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2024-08-12
10097604245552Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2024-08-12
10097604956007Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2024-08-12
10097604956052Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2024-08-12
10097604956106Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2024-08-12
10097604956205Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2024-08-12
10097604956304Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2024-08-12
10097604956359Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2024-08-12
10097604956403Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2024-08-12
10097604956458Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2024-08-12
10097604956502Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2024-08-12
10097604956557Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2024-08-12
10195327657802Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYU2024-07-29
10097604245064Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2023-08-28
10097604245163Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2023-08-28
10097604245262Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2023-08-28
10097604245361Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2023-08-28
10097604245460Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2023-08-28
10097604245569Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2023-08-28
10097604245668Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2023-08-28
10097604245767Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2023-08-28
10097604245866Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2023-08-28