REDFIELD CORPORATION

GUDID 00888937013504

REDFIELD IRC 2100™

Coopersurgical, Inc.

Infrared tissue coagulation system
Primary Device ID00888937013504
NIH Device Record Keyba734024-7e21-4c0d-a13a-d8a2ff60cef1
Commercial Distribution StatusIn Commercial Distribution
Brand NameREDFIELD CORPORATION
Version Model NumberIRC-HS1
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 Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100888937013504 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KNSUnit, Electrosurgical, Endoscopic (With Or Without Accessories)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-08-10

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00888937023817 - K-Systems2024-02-27 L126 IVF, Standard Heat Right

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