Ergobench Adjustable Table

GUDID 00850008449628

PIVOTAL HEALTH SOLUTIONS, INC.

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Primary Device ID00850008449628
NIH Device Record Key834a4122-a2b5-4612-be93-f01225200e79
Commercial Distribution StatusIn Commercial Distribution
Brand NameErgobench Adjustable Table
Version Model NumberEB9010
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
GS100850008449628 [Primary]

FDA Product Code

INWTable, Mechanical

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

Devices Manufactured by PIVOTAL HEALTH SOLUTIONS, INC.

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