Essential Thera-P

GUDID 00850020142330

PIVOTAL HEALTH SOLUTIONS, INC.

Examination/treatment table, line-powered
Primary Device ID00850020142330
NIH Device Record Key0e9b36ad-b371-4891-a970-7158e8610df9
Commercial Distribution StatusIn Commercial Distribution
Brand NameEssential Thera-P
Version Model NumberEPT9028
Company DUNS826316098
Company NamePIVOTAL HEALTH SOLUTIONS, INC.
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
GS100850020142330 [Primary]

FDA Product Code

INQTable, Powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-09-06
Device Publish Date2021-08-27

On-Brand Devices [Essential Thera-P]

00850020142361EPT9025
00850020142354EPT9024
00850020142347EPT9029
00850020142330EPT9028
00850008449963EPT9021
00850008449956EPT9020

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