Knee high boot cover (40g SMS)

GUDID 20376885021015

Knee high boot cover (40g SMS + pvc non slip) [EMS-11311]

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 ID20376885021015
NIH Device Record Key72d0f921-6528-4833-b0fa-a2ee4cc49690
Commercial Distribution StatusIn Commercial Distribution
Brand NameKnee high boot cover (40g SMS)
Version Model NumberEMS-11311
Company DUNS117478411
Company NameEmergency Medical Solutions LLC
Device Count200
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
GS100376885021011 [Unit of Use]
GS120376885021015 [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

Devices Manufactured by Emergency Medical Solutions LLC

20376885018015 - Knee high boot covers (45g SMS)2021-05-20 knee high boot covers (45g SMS + SMS Glue Grip dots non skid bottoms, elastic at ankle) [EMS-11211B]
20376885019012 - Knee high boot covers (45g SMS)2021-05-20 knee high boot covers (45g SMS + SMS Glue Grip dots non skid bottoms (welded), Tie to tighten boat) [EMS-11222]
20376885020018 - Knee high boot covers (45g SMS)2021-05-20 knee high boot covers (45g SMS + 2 strips EVA non skid bottom) [EMS-11211]
20376885021015 - Knee high boot cover (40g SMS)2021-05-20Knee high boot cover (40g SMS + pvc non slip) [EMS-11311]
20376885021015 - Knee high boot cover (40g SMS)2021-05-20 Knee high boot cover (40g SMS + pvc non slip) [EMS-11311]
20376885022012 - Knee high Isolation boot cover (65gsm pp+pe + peva non slip strips) [EMS-11411]2021-05-20 Knee high Isolation boot cover (65gsm pp+pe + peva non slip strips) [EMS-11411]
20376885023019 - Shoe cover (35gsm PP half elastic) [EMS-10221]2021-05-20 Shoe cover (35gsm PP half elastic) [EMS-10221]
20376885024016 - Shoe cover (33gsm PP full elastic) [EMS-10211]2021-05-20
20376885025013 - Shoe cover (40gsm PP half elastic) [EMS-10232]2021-05-20 Shoe cover (40gsm PP half elastic) [EMS-10232]

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