Epidural Positioning Device

GUDID 00850008449550

PIVOTAL HEALTH SOLUTIONS, INC.

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Primary Device ID00850008449550
NIH Device Record Key43506198-5508-48f6-99ad-58b0311f5f94
Commercial Distribution StatusIn Commercial Distribution
Brand NameEpidural Positioning Device
Version Model NumberEPD Package 2
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
GS100850008449550 [Primary]

FDA Product Code

FWZOperating Room Accessories Table Tray

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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