Hygoformic Bio UB100

GUDID 07393507113131

Saliva ejector

J.H. Orsing AB

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Primary Device ID07393507113131
NIH Device Record Key204cbc49-3d01-4353-b837-c1256bc46955
Commercial Distribution StatusIn Commercial Distribution
Brand NameHygoformic Bio
Version Model NumberHygoformic
Catalog NumberUB100
Company DUNS354287922
Company NameJ.H. Orsing AB
Device Count100
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]
GS107393507112073 [Primary]
GS107393507113131 [Package]
Contains: 07393507112073
Package: [20 Units]
In Commercial Distribution

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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