Uterine ElevatOR PRO with OccludOR Balloon™ UE-OBPRO-37NT

GUDID 19349967004972

THE O R COMPANY PTY LTD

Uterine manipulator, single-use Uterine manipulator, single-use Uterine manipulator, single-use Uterine manipulator, single-use Uterine manipulator, single-use Uterine manipulator, single-use Uterine manipulator, single-use Uterine manipulator, single-use Uterine manipulator, single-use Uterine manipulator, single-use Uterine manipulator, single-use Uterine manipulator, single-use Uterine manipulator, single-use Uterine manipulator, single-use Uterine manipulator, single-use Uterine manipulator, single-use Uterine manipulator, single-use
Primary Device ID19349967004972
NIH Device Record Key08ee105e-5bf4-4e6c-ac95-0bfcff8691f3
Commercial Distribution StatusIn Commercial Distribution
Brand NameUterine ElevatOR PRO with OccludOR Balloon™
Version Model NumberUE-OBPRO-37NT
Catalog NumberUE-OBPRO-37NT
Company DUNS744346235
Company NameTHE O R COMPANY PTY LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Outer Diameter37 Millimeter
Outer Diameter37 Millimeter
Outer Diameter37 Millimeter
Outer Diameter37 Millimeter
Outer Diameter37 Millimeter
Outer Diameter37 Millimeter
Outer Diameter37 Millimeter
Outer Diameter37 Millimeter
Outer Diameter37 Millimeter
Outer Diameter37 Millimeter
Outer Diameter37 Millimeter
Outer Diameter37 Millimeter
Outer Diameter37 Millimeter
Outer Diameter37 Millimeter
Outer Diameter37 Millimeter
Outer Diameter37 Millimeter
Outer Diameter37 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS109349967004975 [Primary]
GS119349967004972 [Package]
Contains: 09349967004975
Package: Outer box [8 Units]
In Commercial Distribution
GS129349967004979 [Package]
Package: Shipper box [6 Units]
In Commercial Distribution

FDA Product Code

LKFCannula, Manipulator/Injector, Uterine

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-06-05
Device Publish Date2023-05-26

On-Brand Devices [Uterine ElevatOR PRO with OccludOR Balloon™]

19349967005016UE-OBPRO-32NT
19349967004989UE-OBPRO-40NT
19349967004972UE-OBPRO-37NT
19349967004965UE-OBPRO-35NT

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