Hygiene bag FL for Imaging Plate Systems SIZE 1 200PCS

GUDID 06430035873173

PaloDEx Group Oy

Medical equipment drape, single-use, non-sterile
Primary Device ID06430035873173
NIH Device Record Key2a4d04a3-cd6d-405b-973b-c0a9baa6c976
Commercial Distribution StatusIn Commercial Distribution
Brand NameHygiene bag FL for Imaging Plate Systems SIZE 1 200PCS
Version Model Number900371
Company DUNS459955188
Company NamePaloDEx Group Oy
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 Batchfalse
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106430035873173 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PEMDental Barriers And Sleeves

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-02-10
Device Publish Date2020-02-01

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