Hygoformic Bio UB1000

GUDID 07393507111076

Saliva ejector

J.H. Orsing AB

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Primary Device ID07393507111076
NIH Device Record Keycad7e9ff-df88-4700-9502-2db970beeda9
Commercial Distribution StatusIn Commercial Distribution
Brand NameHygoformic Bio
Version Model NumberHygoformic
Catalog NumberUB1000
Company DUNS354287922
Company NameJ.H. Orsing AB
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 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
GS107393507111076 [Unit of Use]
GS107393507112127 [Primary]
GS107393507112141 [Primary]

FDA Product Code

DYNMouthpiece, Saliva Ejector

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-12-14
Device Publish Date2022-12-06

On-Brand Devices [Hygoformic Bio]

07393507111076Saliva ejector
07393507113131Saliva ejector

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