Roller Massage Table

GUDID 00852753008990

PIVOTAL HEALTH SOLUTIONS, INC.

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Primary Device ID00852753008990
NIH Device Record Keya055a140-3f20-4a31-b265-1a739cd76959
Commercial Distribution StatusIn Commercial Distribution
Brand NameRoller Massage Table
Version Model NumberIST-350
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
GS100852753008990 [Primary]

FDA Product Code

ISAMassager, Therapeutic, Electric

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 [Roller Massage Table]

00852753008990IST-350
00852753008983TR1000
00852753008976ATT-300

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