Cast Elevator CE1

GUDID 00810006683011

Cast Elevator (19.5"L x 12"W x 9"H)

PRIMO INC

Freestanding patient positioner, single-use
Primary Device ID00810006683011
NIH Device Record Key45185411-ad2d-44b1-96fc-10b2c447df31
Commercial Distribution StatusIn Commercial Distribution
Brand NameCast Elevator
Version Model NumberCE1
Catalog NumberCE1
Company DUNS958758146
Company NamePRIMO 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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
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
GS100810006681611 [Primary]
GS100810006683011 [Package]
Contains: 00810006681611
Package: CASE [4 Units]
In Commercial Distribution

FDA Product Code

ILZAccessories, Traction

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-03-11
Device Publish Date2019-02-20

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