RocaFlow Irrigation warming System MEN01

GUDID 03700512956181

ENDOFLOW II - Single Chamber Olympus

Promepla

Surgical irrigation/aspiration system
Primary Device ID03700512956181
NIH Device Record Key9840e2e5-087b-4e0c-a93d-fa9745c946a6
Commercial Distribution StatusIn Commercial Distribution
Brand NameRocaFlow Irrigation warming System
Version Model NumberMEN01US-245
Catalog NumberMEN01
Company DUNS401020409
Company NamePromepla
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 Datetrue
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
GS103700512955184 [Primary]
GS103700512956181 [Package]
Contains: 03700512955184
Package: Box [1 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OCXEndoscopic Irrigation/Suction System

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-11-11
Device Publish Date2019-10-29

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