Splash Shield Lite

GUDID 10781963454075

Sold as box of 200

BERKLEY MEDICAL RESOURCES, INC.

Face splash shield, single-use
Primary Device ID10781963454075
NIH Device Record Keyd4658af6-9fb7-41d4-b709-526c676218dd
Commercial Distribution StatusIn Commercial Distribution
Brand NameSplash Shield Lite
Version Model Number4540LCMU
Company DUNS077359201
Company NameBERKLEY MEDICAL RESOURCES, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS110781963454075 [Primary]

FDA Product Code

FXXMask, Surgical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2020-04-06
Device Publish Date2016-09-05

On-Brand Devices [Splash Shield Lite]

00781963454221Sold as box of 40
00781963454115Sold as box of 40
00781963454108Sold as box of 40
00781963454078Sold as box of 40
00781963454023Sold as box of 40
00781963452227Sold as box of 20
10781963454228Sold as box of 200
10781963454112Sold as box of 200
10781963454105Sold as box of 200
10781963454075Sold as box of 200
10781963454020Sold as box of 200
10781963452224Sold as box of 200

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.