FDA.reportPublic FDA data

Splash Shield

Primary DI
00781963450537
Brand
Splash Shield
Company
BERKLEY MEDICAL RESOURCES, INC.
Model
4505E
Device description
Sold as box of 444
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
00781963450537PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00781963450537007819634505377819634505370781963450537

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
00781963451107Splash Shield4511A2016-09-05
00781963451114Splash Shield45112016-09-05
00781963452227Splash Shield Lite4522BMU2016-09-05
00781963454023Splash Shield Lite4540SBMU2016-09-05
00781963454078Splash Shield Lite4540LBMU2016-09-05
00781963454108Splash Shield Lite4541SBU2016-09-05
00781963454115Splash Shield Lite4541LBU2016-09-05
00781963454221Splash Shield Lite4542BM2016-09-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850086117037Resilient Medical SolutionsResilient Medical Solutions, LLCFXX2026-07-08
00840456202722JMUJMU DENTAL, INCFXX2026-07-07
00840456202739JMUJMU DENTAL, INCFXX2026-07-07
00840456202746JMUJMU DENTAL, INCFXX2026-07-07
00840456214619JMUJMU DENTAL, INCFXX2026-07-07
00840456214626JMUJMU DENTAL, INCFXX2026-07-07
00840456214633JMUJMU DENTAL, INCFXX2026-07-07
00840456214640JMUJMU DENTAL, INCFXX2026-07-07
00840456214657JMUJMU DENTAL, INCFXX2026-07-07
00850056441261Target Up&UpArmbrust Inc.FXX2026-06-25
00850056441254Target Up&UpArmbrust Inc.FXX2026-06-25
16980077680262AOKAOK TOOLING LIMITEDFXX2026-06-24
16980077680255AOKAOK TOOLING LIMITEDFXX2026-06-22
00842942008894PRIMEDpriMED Medical Products IncFXX2026-06-21
06922820992584GraidRfx+Care Manufacturing Co., Ltd.FXX2026-06-09
16980077680217AOKAOK TOOLING LIMITEDFXX2026-06-08
16980077680224AOKAOK TOOLING LIMITEDFXX2026-06-08
16980077680231AOKAOK TOOLING LIMITEDFXX2026-06-08
16980077680248AOKAOK TOOLING LIMITEDFXX2026-06-08
16980077680170AOKAOK TOOLING LIMITEDFXX2026-06-05
16980077680187AOKAOK TOOLING LIMITEDFXX2026-06-05
16980077680194AOKAOK TOOLING LIMITEDFXX2026-06-05
16980077680200AOKAOK TOOLING LIMITEDFXX2026-06-05
16980077680149AOKAOK TOOLING LIMITEDFXX2026-06-04
16980077680156AOKAOK TOOLING LIMITEDFXX2026-06-04
16980077680163AOKAOK TOOLING LIMITEDFXX2026-06-04
16980077680101AOKAOK TOOLING LIMITEDFXX2026-06-03
16980077680118AOKAOK TOOLING LIMITEDFXX2026-06-03
16980077680125AOKAOK TOOLING LIMITEDFXX2026-06-03
16980077680132AOKAOK TOOLING LIMITEDFXX2026-06-03