Clarke-Reich Macro

GUDID 00888937011432

Laparoscopic Knot Pusher; 5-0 and Larger; 45cm working length

Coopersurgical, Inc.

Needle holder, reusable
Primary Device ID00888937011432
NIH Device Record Keyfafa98ed-5f3e-440b-a23c-4e50009986d7
Commercial Distribution StatusIn Commercial Distribution
Brand NameClarke-Reich Macro
Version Model NumberM4601P
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Outer Diameter5 Millimeter
Outer Diameter5 Millimeter
Outer Diameter5 Millimeter
Outer Diameter5 Millimeter
Outer Diameter5 Millimeter
Outer Diameter5 Millimeter
Outer Diameter5 Millimeter
Outer Diameter5 Millimeter
Outer Diameter5 Millimeter
Outer Diameter5 Millimeter
Outer Diameter5 Millimeter
Outer Diameter5 Millimeter
Outer Diameter5 Millimeter
Outer Diameter5 Millimeter
Outer Diameter5 Millimeter
Outer Diameter5 Millimeter
Outer Diameter5 Millimeter
Outer Diameter5 Millimeter
Outer Diameter5 Millimeter
Outer Diameter5 Millimeter
Outer Diameter5 Millimeter
Outer Diameter5 Millimeter
Outer Diameter5 Millimeter
Outer Diameter5 Millimeter
Outer Diameter5 Millimeter
Outer Diameter5 Millimeter
Outer Diameter5 Millimeter
Outer Diameter5 Millimeter
Outer Diameter5 Millimeter
Outer Diameter5 Millimeter
Outer Diameter5 Millimeter
Outer Diameter5 Millimeter
Outer Diameter5 Millimeter
Outer Diameter5 Millimeter
Outer Diameter5 Millimeter
Outer Diameter5 Millimeter
Outer Diameter5 Millimeter
Outer Diameter5 Millimeter
Outer Diameter5 Millimeter
Outer Diameter5 Millimeter
Outer Diameter5 Millimeter
Outer Diameter5 Millimeter
Outer Diameter5 Millimeter
Outer Diameter5 Millimeter
Outer Diameter5 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100888937011432 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HETLaparoscope, Gynecologic (And Accessories)

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00888937011432]

Moist Heat or Steam Sterilization;Liquid Chemical;Ethylene Oxide


[00888937011432]

Moist Heat or Steam Sterilization;Liquid Chemical;Ethylene Oxide


[00888937011432]

Moist Heat or Steam Sterilization;Liquid Chemical;Ethylene Oxide


[00888937011432]

Moist Heat or Steam Sterilization;Liquid Chemical;Ethylene Oxide


[00888937011432]

Moist Heat or Steam Sterilization;Liquid Chemical;Ethylene Oxide


[00888937011432]

Moist Heat or Steam Sterilization;Liquid Chemical;Ethylene Oxide


[00888937011432]

Moist Heat or Steam Sterilization;Liquid Chemical;Ethylene Oxide


[00888937011432]

Moist Heat or Steam Sterilization;Liquid Chemical;Ethylene Oxide


[00888937011432]

Moist Heat or Steam Sterilization;Liquid Chemical;Ethylene Oxide


[00888937011432]

Moist Heat or Steam Sterilization;Liquid Chemical;Ethylene Oxide


[00888937011432]

Moist Heat or Steam Sterilization;Liquid Chemical;Ethylene Oxide


[00888937011432]

Moist Heat or Steam Sterilization;Liquid Chemical;Ethylene Oxide


[00888937011432]

Moist Heat or Steam Sterilization;Liquid Chemical;Ethylene Oxide


[00888937011432]

Moist Heat or Steam Sterilization;Liquid Chemical;Ethylene Oxide


[00888937011432]

Moist Heat or Steam Sterilization;Liquid Chemical;Ethylene Oxide


[00888937011432]

Moist Heat or Steam Sterilization;Liquid Chemical;Ethylene Oxide


[00888937011432]

Moist Heat or Steam Sterilization;Liquid Chemical;Ethylene Oxide


[00888937011432]

Moist Heat or Steam Sterilization;Liquid Chemical;Ethylene Oxide


[00888937011432]

Moist Heat or Steam Sterilization;Liquid Chemical;Ethylene Oxide


[00888937011432]

Moist Heat or Steam Sterilization;Liquid Chemical;Ethylene Oxide


[00888937011432]

Moist Heat or Steam Sterilization;Liquid Chemical;Ethylene Oxide


[00888937011432]

Moist Heat or Steam Sterilization;Liquid Chemical;Ethylene Oxide


[00888937011432]

Moist Heat or Steam Sterilization;Liquid Chemical;Ethylene Oxide


[00888937011432]

Moist Heat or Steam Sterilization;Liquid Chemical;Ethylene Oxide


[00888937011432]

Moist Heat or Steam Sterilization;Liquid Chemical;Ethylene Oxide


[00888937011432]

Moist Heat or Steam Sterilization;Liquid Chemical;Ethylene Oxide


[00888937011432]

Moist Heat or Steam Sterilization;Liquid Chemical;Ethylene Oxide


[00888937011432]

Moist Heat or Steam Sterilization;Liquid Chemical;Ethylene Oxide


[00888937011432]

Moist Heat or Steam Sterilization;Liquid Chemical;Ethylene Oxide


[00888937011432]

Moist Heat or Steam Sterilization;Liquid Chemical;Ethylene Oxide


[00888937011432]

Moist Heat or Steam Sterilization;Liquid Chemical;Ethylene Oxide


[00888937011432]

Moist Heat or Steam Sterilization;Liquid Chemical;Ethylene Oxide


[00888937011432]

Moist Heat or Steam Sterilization;Liquid Chemical;Ethylene Oxide


[00888937011432]

Moist Heat or Steam Sterilization;Liquid Chemical;Ethylene Oxide


[00888937011432]

Moist Heat or Steam Sterilization;Liquid Chemical;Ethylene Oxide


[00888937011432]

Moist Heat or Steam Sterilization;Liquid Chemical;Ethylene Oxide


[00888937011432]

Moist Heat or Steam Sterilization;Liquid Chemical;Ethylene Oxide


[00888937011432]

Moist Heat or Steam Sterilization;Liquid Chemical;Ethylene Oxide


[00888937011432]

Moist Heat or Steam Sterilization;Liquid Chemical;Ethylene Oxide


[00888937011432]

Moist Heat or Steam Sterilization;Liquid Chemical;Ethylene Oxide


[00888937011432]

Moist Heat or Steam Sterilization;Liquid Chemical;Ethylene Oxide


[00888937011432]

Moist Heat or Steam Sterilization;Liquid Chemical;Ethylene Oxide


[00888937011432]

Moist Heat or Steam Sterilization;Liquid Chemical;Ethylene Oxide


[00888937011432]

Moist Heat or Steam Sterilization;Liquid Chemical;Ethylene Oxide


[00888937011432]

Moist Heat or Steam Sterilization;Liquid Chemical;Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-07-06
Device Publish Date2016-09-21

On-Brand Devices [Clarke-Reich Macro]

00888937011432Laparoscopic Knot Pusher; 5-0 and Larger; 45cm working length
00888937011401Laparoscopic Knot Pusher; 5-0 and Larger; 29cm working length

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