Huanfu

GUDID 06974239590004

Hubei Huanfu Plastic Products Co., Ltd.

Shoe cover
Primary Device ID06974239590004
NIH Device Record Keya6e37284-6d5d-452b-ab1a-fe7116b990a0
Commercial Distribution StatusIn Commercial Distribution
Brand NameHuanfu
Version Model Numberblue,15x41cm,CPE 3.8g/pc,hand-made
Company DUNS530032259
Company NameHubei Huanfu Plastic Products Co., Ltd.
Device Count1000
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 Batchtrue
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
GS106974239590004 [Unit of Use]
GS126974239590008 [Primary]
GS126974239590060 [Primary]
GS126974239590077 [Primary]

FDA Product Code

FXPCover, Shoe, Operating-Room
KMEBedding, Disposable, Medical
OEANon-Surgical Isolation Gown

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-11-22
Device Publish Date2022-11-14

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