Cannula-Curette with 60 cc Handyvak Syringe

GUDID 20888937000935

Stainless Steel Curette 3mm OD

Coopersurgical, Inc.

Endometrial biopsy kit
Primary Device ID20888937000935
NIH Device Record Key12daea40-288b-45f6-89cb-8f7868cb0a16
Commercial Distribution StatusIn Commercial Distribution
Brand NameCannula-Curette with 60 cc Handyvak Syringe
Version Model NumberMX623
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 Diameter3 Millimeter
Outer Diameter3 Millimeter
Outer Diameter3 Millimeter
Outer Diameter3 Millimeter
Outer Diameter3 Millimeter
Outer Diameter3 Millimeter
Outer Diameter3 Millimeter
Outer Diameter3 Millimeter
Outer Diameter3 Millimeter
Outer Diameter3 Millimeter
Outer Diameter3 Millimeter
Outer Diameter3 Millimeter
Outer Diameter3 Millimeter
Outer Diameter3 Millimeter
Outer Diameter3 Millimeter
Outer Diameter3 Millimeter
Outer Diameter3 Millimeter
Outer Diameter3 Millimeter
Outer Diameter3 Millimeter
Outer Diameter3 Millimeter
Outer Diameter3 Millimeter
Outer Diameter3 Millimeter
Outer Diameter3 Millimeter
Outer Diameter3 Millimeter
Outer Diameter3 Millimeter
Outer Diameter3 Millimeter
Outer Diameter3 Millimeter
Outer Diameter3 Millimeter
Outer Diameter3 Millimeter
Outer Diameter3 Millimeter
Outer Diameter3 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100888937000931 [Primary]
GS120888937000935 [Package]
Contains: 00888937000931
Package: [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HHKCurette, Suction, Endometrial (And Accessories)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-08-15

Devices Manufactured by Coopersurgical, Inc.

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60888937027206 - ERPeak2024-04-18 IVD Sample kit
00888937026870 - Mara Console2024-03-21 Mara Console- Endometrial Ablation
00888937023817 - K-Systems2024-02-27 L126 IVF, Standard Heat Right

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