UR-NEXT4KH

GUDID 04907034602186

TEAC MANUFACTURING SOLUTIONS CORPORATION

Medical video image recorder
Primary Device ID04907034602186
NIH Device Record Key8899eee1-839a-4ae8-b508-249c9a9c10b0
Commercial Distribution StatusIn Commercial Distribution
Brand NameUR-NEXT4KH
Version Model Number1921070130
Company DUNS693002487
Company NameTEAC MANUFACTURING SOLUTIONS CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
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
GS104907034602186 [Primary]

FDA Product Code

LMBDevice, Digital Image Storage, Radiological

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-11-10
Device Publish Date2022-11-02

On-Brand Devices [UR-NEXT4KH]

049070346021931921070150
049070346021861921070130

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