Uterine ElevatOR PRO with Long Handle™ UE-LHPRO-32NT

GUDID 19349967005061

THE O R COMPANY PTY LTD

Uterine manipulator, single-use
Primary Device ID19349967005061
NIH Device Record Keyb81543c3-cee0-480b-b870-d994a1b3eb28
Commercial Distribution StatusIn Commercial Distribution
Brand NameUterine ElevatOR PRO with Long Handle™
Version Model NumberUE-LHPRO-32NT
Catalog NumberUE-LHPRO-32NT
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 Diameter32 Millimeter
Outer Diameter32 Millimeter
Outer Diameter32 Millimeter
Outer Diameter32 Millimeter
Outer Diameter32 Millimeter
Outer Diameter32 Millimeter
Outer Diameter32 Millimeter
Outer Diameter32 Millimeter
Outer Diameter32 Millimeter
Outer Diameter32 Millimeter
Outer Diameter32 Millimeter
Outer Diameter32 Millimeter
Outer Diameter32 Millimeter
Outer Diameter32 Millimeter
Outer Diameter32 Millimeter
Outer Diameter32 Millimeter
Outer Diameter32 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS109349967005064 [Primary]
GS119349967005061 [Package]
Contains: 09349967005064
Package: Outer Box [8 Units]
In Commercial Distribution
GS129349967005068 [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 Long Handle™]

19349967005092UE-LHPRO-40NT
19349967005085UE-LHPRO-37NT
19349967005078UE-LHPRO-35NT
19349967005061UE-LHPRO-32NT

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