ClearView Uterine Manipulator

GUDID 20814247020479

ClearView Uterine Manipulator, regular tip

CLINICAL INNOVATIONS, LLC

Uterine manipulator, single-use
Primary Device ID20814247020479
NIH Device Record Keye0aed406-33c1-42c3-b61e-73fb887f9eb1
Commercial Distribution StatusIn Commercial Distribution
Brand NameClearView Uterine Manipulator
Version Model NumberUM201
Company DUNS809524291
Company NameCLINICAL INNOVATIONS, LLC
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100814247020475 [Primary]
GS110814247020472 [Package]
Contains: 00814247020475
Package: [5 Units]
In Commercial Distribution
GS120814247020479 [Package]
Contains: 10814247020472
Package: [4 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LKFCannula, Manipulator/Injector, Uterine

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-12-07
Device Publish Date2016-09-01

On-Brand Devices [ClearView Uterine Manipulator]

20814247020608ClearView Uterine Manipulator, 9cm
20814247020486ClearView Uterine Manipulator, long tip
20814247020479ClearView Uterine Manipulator, regular tip
20814247020011ClearView Uterine Manipulator, 7cm

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