FDA.reportPublic FDA data

Splash Shield Lite

Primary DI
00781963454108
Brand
Splash Shield Lite
Company
BERKLEY MEDICAL RESOURCES, INC.
Model
4541SBU
Device description
Sold as box of 40
Published
2016-09-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
FXXMask, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FXXMask, SurgicalGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00781963454108PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00781963454108007819634541087819634541080781963454108

GMDN Terms#

Term, Definition table
TermDefinition
Face splash shieldA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
077359201
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10781963450510Splash Shield4505B2016-09-05
10781963451111Splash Shield4511B2016-09-05
10781963452224Splash Shield Lite4522CMU2016-09-05
10781963454020Splash Shield Lite4540SCMU2016-09-05
10781963454075Splash Shield Lite4540LCMU2016-09-05
10781963454105Splash Shield Lite4541SCU2016-09-05
10781963454112Splash Shield Lite4541LCU2016-09-05
10781963454228Splash Shield Lite4542CM2016-09-05
00781963450506Splash Shield4505A2016-09-05
00781963450513Splash Shield45052016-09-05
00781963450537Splash Shield4505E2016-09-05
00781963451107Splash Shield4511A2016-09-05
00781963451114Splash Shield45112016-09-05
00781963452227Splash Shield Lite4522BMU2016-09-05
00781963454023Splash Shield Lite4540SBMU2016-09-05
00781963454078Splash Shield Lite4540LBMU2016-09-05
00781963454115Splash Shield Lite4541LBU2016-09-05
00781963454221Splash Shield Lite4542BM2016-09-05

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00681131106108EquateWAL-MART STORES, INC.FXX2026-02-25
00681131106092EquateWAL-MART STORES, INC.FXX2026-02-25
08809755250171KP Protective Face Mask KP trading Co., Ltd.FXX2026-02-19
10097604555514Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXX2025-07-28
10371347011606Advance Dental ProductsThe Atlanta Dental Supply CompanyFXX2024-03-01
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10097604543320Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXX2024-01-19
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