Advincula Delineator Uterine Manipulator

GUDID 20888937021343

Advincula Delineator Uterine Manipulator with 2.5cm Soft Koh-Efficient

Coopersurgical, Inc.

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Primary Device ID20888937021343
NIH Device Record Key6f1f3d28-3527-4fbe-9d15-9768683bf2ef
Commercial Distribution StatusIn Commercial Distribution
Brand NameAdvincula Delineator Uterine Manipulator
Version Model NumberAD750SC-KE25
Company DUNS801895244
Company NameCoopersurgical, Inc.
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 Diameter2.5 Centimeter
Outer Diameter2.5 Centimeter
Outer Diameter2.5 Centimeter
Outer Diameter2.5 Centimeter
Outer Diameter2.5 Centimeter
Outer Diameter2.5 Centimeter
Outer Diameter2.5 Centimeter
Outer Diameter2.5 Centimeter
Outer Diameter2.5 Centimeter
Outer Diameter2.5 Centimeter
Outer Diameter2.5 Centimeter
Outer Diameter2.5 Centimeter
Outer Diameter2.5 Centimeter
Outer Diameter2.5 Centimeter
Outer Diameter2.5 Centimeter
Outer Diameter2.5 Centimeter
Outer Diameter2.5 Centimeter
Outer Diameter2.5 Centimeter
Outer Diameter2.5 Centimeter
Outer Diameter2.5 Centimeter
Outer Diameter2.5 Centimeter
Outer Diameter2.5 Centimeter
Outer Diameter2.5 Centimeter
Outer Diameter2.5 Centimeter
Outer Diameter2.5 Centimeter
Outer Diameter2.5 Centimeter
Outer Diameter2.5 Centimeter
Outer Diameter2.5 Centimeter
Outer Diameter2.5 Centimeter
Outer Diameter2.5 Centimeter
Outer Diameter2.5 Centimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100888937021349 [Primary]
GS120888937021343 [Package]
Contains: 00888937021349
Package: [3 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HEWCuldoscope (And Accessories)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-12-07
Device Publish Date2018-08-13

On-Brand Devices [Advincula Delineator Uterine Manipulator]

20888937021374Advincula Delineator Uterine Manipulator with 4.0cm Soft Koh-Efficient
20888937021367Advincula Delineator Uterine Manipulator with 3.5cm Soft Koh-Efficient
20888937021350Advincula Delineator Uterine Manipulator with 3.0cm Soft Koh-Efficient
20888937021343Advincula Delineator Uterine Manipulator with 2.5cm Soft Koh-Efficient

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