RevoWave™ RWHJ-3545SJ

GUDID 14545428038363

0.035 Hard

PIOLAX MEDICAL DEVICES, INC.

Gastro-urological guidewire, single-use
Primary Device ID14545428038363
NIH Device Record Keya9d48f6e-88e4-4755-b184-0ca52713b7a8
Commercial Distribution StatusIn Commercial Distribution
Brand NameRevoWave™
Version Model NumberRWHJ-3545SJ
Catalog NumberRWHJ-3545SJ
Company DUNS693961984
Company NamePIOLAX MEDICAL DEVICES, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Length450 Centimeter
Length450 Centimeter
Length450 Centimeter
Length450 Centimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Avoid exposure to high temperature, high humidity, direct sunlight, ultraviolet light (from germicidal lamp, etc.) and water during storage.
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid exposure to high temperature, high humidity, direct sunlight, ultraviolet light (from germicidal lamp, etc.) and water during storage.

Device Identifiers

Device Issuing AgencyDevice ID
GS104545428038366 [Primary]
GS114545428038363 [Package]
Contains: 04545428038366
Package: Carton [1 Units]
In Commercial Distribution

FDA Product Code

OCYEndoscopic Guidewire, Gastroenterology-Urology

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-04-01
Device Publish Date2019-03-22

On-Brand Devices [RevoWave™]

145454280387140.025 Hard
145454280387070.025 Hard
145454280386910.035 Hard
145454280386840.035 Hard
145454280386460.025 UltraHard
145454280386390.035 Standard
145454280383700.025 Hard
145454280383630.035 Hard
145454280383560.025 Hard
145454280383490.025 Hard
145454280383320.025 UltraHard
145454280383250.035 Standard
145454280383180.035 Standard
145454280383010.035 Standard
145454280382950.035 UltraHard
145454280382880.035 Hard
045454280382740.035 Hard
145454280382640.035 Standard
145454280382570.035 Standard

Trademark Results [RevoWave]

Mark Image

Registration | Serial
Company
Trademark
Application Date
REVOWAVE
REVOWAVE
88248761 not registered Live/Pending
Kabushiki Kaisha Piolax Medical Device
2019-01-03

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