Knee high boot covers (45g SMS)

GUDID 20376885020018

knee high boot covers (45g SMS + 2 strips EVA non skid bottom) [EMS-11211]

Emergency Medical Solutions LLC

Shoe cover Shoe cover Shoe cover Shoe cover Shoe cover Shoe cover Shoe cover Shoe cover Shoe cover Shoe cover Shoe cover Shoe cover Shoe cover Shoe cover Shoe cover Shoe cover
Primary Device ID20376885020018
NIH Device Record Key009fd418-5be4-4bfd-8fd3-e8593072ab2a
Commercial Distribution StatusIn Commercial Distribution
Brand NameKnee high boot covers (45g SMS)
Version Model NumberEMS-11211
Company DUNS117478411
Company NameEmergency Medical Solutions LLC
Device Count400
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
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
GS100376885020014 [Unit of Use]
GS120376885020018 [Primary]

FDA Product Code

FXPCover, Shoe, Operating-Room

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-05-20
Device Publish Date2021-05-12

On-Brand Devices [ Knee high boot covers (45g SMS)]

20376885020018knee high boot covers (45g SMS + 2 strips EVA non skid bottom) [EMS-11211]
20376885019012knee high boot covers (45g SMS + SMS Glue Grip dots non skid bottoms (welded), Tie to tighten b
20376885018015knee high boot covers (45g SMS + SMS Glue Grip dots non skid bottoms, elastic at ankle) [EMS-1

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