FDA.reportPublic FDA data

RevoWave™

Primary DI
14545428038257
Brand
RevoWave™
Company
PIOLAX MEDICAL DEVICES, INC.
Model
RWSS-3545I
Catalog number
RWSS-3545I
Device description
0.035 Standard
Published
2019-03-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
OCYEndoscopic Guidewire, Gastroenterology-Urology

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OCYEndoscopic Guidewire, Gastroenterology-UrologyGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14545428038257PackageGS11In Commercial Distribution
04545428038250PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1454542803825714545428038257
04545428038250045454280382504545428038250

GMDN Terms#

Term, Definition table
TermDefinition
Gastro-urological guidewire, single-useA sterile metal coil or wire intended to assist the insertion/positioning of a diagnostic/therapeutic device(s) [e.g., endoscope, catheter] within the gastrointestinal (GI) and/or urinary tract. It is typically coated with a plastic material [e.g., polytetrafluoroethylene (PTFE), commonly known as Teflon, or polyethylene (PE)]. It may have radiopaque graduated markings at the distal end to assist in the fluoroscopic monitoring of its advancement/position within the body. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length450Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Avoid exposure to high temperature, high humidity, direct sunlight, ultraviolet light (from germicidal lamp, etc.) and water during storage.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
693961984
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04545428038250RevoWave™RWSS-3545IRWSS-3545I2019-03-22
04545428038267RevoWave™RWSA-3545IRWSA-3545I2019-03-22
04545428038281RevoWave™RWHA-3545IRWHA-3545I2019-03-22
04545428038298RevoWave™RWUA-3545PRWUA-3545P2019-03-22
04545428038304RevoWave™RWSS-3526IRWSS-3526I2019-03-22
04545428038311RevoWave™RWSA-3526IRWSA-3526I2019-03-22
04545428038328RevoWave™RWSA-3555IRWSA-3555I2019-03-22
04545428038335RevoWave™RWUA-2555IRWUA-2555I2019-03-22
04545428038342RevoWave™RWHS-2545IRWHS-2545I2019-03-22
04545428038359RevoWave™RWHA-2545IRWHA-2545I2019-03-22
04545428038366RevoWave™RWHJ-3545SJRWHJ-3545SJ2019-03-22
04545428038373RevoWave™RWHJ-2545SJRWHJ-2545SJ2019-03-22
04545428038632RevoWave™RWSS-3555IRWSS-3555I2019-03-22
04545428038649RevoWave™RWUS-2555IRWUS-2555I2019-03-22
04545428038687RevoWave™RWHS-3526IDRWHS-3526ID2019-03-22
04545428038694RevoWave™RWHA-3526IDRWHA-3526ID2019-03-22
04545428038700RevoWave™RWHA-2526IDRWHA-2526ID2019-03-22
04545428038717RevoWave™RWHS-2526IDRWHS-2526ID2019-03-22
04545428038274RevoWave™RWHS-3545IRWHS-3545I2019-03-22
14545428038264RevoWave™RWSA-3545IRWSA-3545I2019-03-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809909421532GuidewireTAEWOONGMEDICAL.CO.,LTDOCY2026-04-24
08809909421549GuidewireTAEWOONGMEDICAL.CO.,LTDOCY2026-04-24
08809909421556GuidewireTAEWOONGMEDICAL.CO.,LTDOCY2026-04-24
08809909421563GuidewireTAEWOONGMEDICAL.CO.,LTDOCY2026-04-24
08809909421570GuidewireTAEWOONGMEDICAL.CO.,LTDOCY2026-04-24
08809909421587GuidewireTAEWOONGMEDICAL.CO.,LTDOCY2026-04-24
08809909421594GuidewireTAEWOONGMEDICAL.CO.,LTDOCY2026-04-24
08809909421600GuidewireTAEWOONGMEDICAL.CO.,LTDOCY2026-04-24
04953170465055VISIGLIDETERUMO CORPORATIONOCY2025-07-14
04953170465062VISIGLIDETERUMO CORPORATIONOCY2025-07-14
04953170465079VISIGLIDETERUMO CORPORATIONOCY2025-07-14
04953170465086VISIGLIDETERUMO CORPORATIONOCY2025-07-14
04953170465093VISIGLIDETERUMO CORPORATIONOCY2025-07-14
04953170465109VISIGLIDETERUMO CORPORATIONOCY2025-07-14
04953170465116VISIGLIDETERUMO CORPORATIONOCY2025-07-14
04953170465123VISIGLIDETERUMO CORPORATIONOCY2025-07-14
04953170465130VISIGLIDE2TERUMO CORPORATIONOCY2025-07-14
04953170465147VISIGLIDE2TERUMO CORPORATIONOCY2025-07-14
04953170465154VISIGLIDE2TERUMO CORPORATIONOCY2025-07-14
04953170465161VISIGLIDE2TERUMO CORPORATIONOCY2025-07-14
04953170465178VISIGLIDE2TERUMO CORPORATIONOCY2025-07-14
04953170465185VISIGLIDE2TERUMO CORPORATIONOCY2025-07-14
04953170465192VISIGLIDE2TERUMO CORPORATIONOCY2025-07-14
04953170465208VISIGLIDE2TERUMO CORPORATIONOCY2025-07-14
05708932767774SopranoColoplast A/SOCY2025-03-26
05708932767804SopranoColoplast A/SOCY2025-03-26
06932503510011Sterile Hydro-Slide GuidewireMicro-Tech (Nanjing) Co., Ltd.OCY2024-08-13
06932503510028Sterile Hydro-Slide GuidewireMicro-Tech (Nanjing) Co., Ltd.OCY2024-08-13
06932503510035Sterile Hydro-Slide GuidewireMicro-Tech (Nanjing) Co., Ltd.OCY2024-08-13
03600040926611ColoplastColoplast A/SOCY2024-04-19