FDA.reportPublic FDA data

RevoWave™

Primary DI
04545428038267
Brand
RevoWave™
Company
PIOLAX MEDICAL DEVICES, INC.
Model
RWSA-3545I
Catalog number
RWSA-3545I
Device description
0.035 Standard
Published
2019-03-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
14545428038264PackageGS11In Commercial Distribution
04545428038267PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1454542803826414545428038264
04545428038267045454280382674545428038267

GMDN Terms#

Term, Definition table
TermDefinition
Gastro-urological guidewire, single-useA 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.

Regulatory Flags#

DUNS number
693961984
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04545428038250RevoWave™RWSS-3545IRWSS-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
14545428038257RevoWave™RWSS-3545IRWSS-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
06932503510042Sterile Hydro-Slide GuidewireMicro-Tech (Nanjing) Co., Ltd.OCY2024-08-13