FDA.reportPublic FDA data

Revita® Guidewire

Primary DI
00816349014833
Brand
Revita® Guidewire
Company
Lake Region Medical
Model
FRABF-001V
Catalog number
50110
Published
2024-12-16
Public version status
New
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
KNTTubes, Gastrointestinal (And Accessories)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNTTubes, Gastrointestinal (And Accessories)Gastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10816349014830PackageGS15In Commercial Distribution
00816349014833PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081634901483010816349014830
00816349014833008163490148338163490148330816349014833

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
Guidewire Diameter0.35Inch
Guidewire Length450Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Dry, KEep away from sunlight

Regulatory Flags#

DUNS number
031108704
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816349012570Safari2H74939661L12026-06-25
00816349012587Safari2H74939661S12026-06-25
00816349012594Safari2H74939661XS12026-06-25
00816349013676WallStentMDTBG-023V2026-06-25
00816349015755IntuitionABFBF-011VIN32180J12026-05-12
00816349013539GuideRight404569-1404569-12026-03-24
00816349013546GuideRight404570-1404570-12026-03-24
00816349013553GuideRight404578-1404578-12026-03-24
00816349013560GuideRight404571-1404571-12026-03-24
00816349013577GuideRight404577-1404577-12026-03-24
00816349013584GuideRight404610-1404610-12026-03-24
00816349013591GuideRight404617-1404617-12026-03-24
00816349013607GuideRight404840-1404840-12026-03-24
00816349013614GuideRight404843-1404843-12026-03-24
00816349013621GuideRight404844-1404844-12026-03-24
00816349013638GuideRight404878-1404878-12026-03-24
00816349013645GuideRight404568-1404568-12026-03-24
00816349013652GuideRight404555-1404555-12026-03-24
00816349013669GuideRight404560-1404560-12026-03-24
10816349013536GuideRight404569-1404569-12026-03-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G461CEGCT40M0EndolumikEndolumik, Inc.KNT2026-08-25
00350770006840CORTRAK* Enteral Access SystemAvanos Medical, Inc.KNT2026-08-21
00350770007922CORTRAK* Enteral Access System - Reusable CableAvanos Medical, Inc.KNT2026-08-21
00350770009094CORTRAK* Enteral Access SystemAvanos Medical, Inc.KNT2026-08-21
00350770009117CORTRAK* Enteral Access System - Reusable CableAvanos Medical, Inc.KNT2026-08-21
00350770007557CORFLO* Safety PEG KitAvanos Medical, Inc.KNT2026-08-14
00842071146436MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-07-17
00842071146443MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-07-17
00842071153083NutraGlide Nasal Feeding TubeAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-06-10
00842071153106NutraGlide Nasal Feeding TubeAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-06-10
00842071153120NutraGlide Nasal Feeding TubeAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-06-10
00816340021632EL-SPIKE-MNEODEVICES INCKNT2026-06-01
00816340021649EL-SPIKE-FNEODEVICES INCKNT2026-06-01
00816340021656EL-S55-HFNEODEVICES INCKNT2026-06-01
10192253006834Salem SumpCardinal Health 200, LLCKNT2026-01-16
10192253006841Salem SumpCardinal Health 200, LLCKNT2026-01-16
10192253006858Salem SumpCardinal Health 200, LLCKNT2026-01-16
10192253006865Salem SumpCardinal Health 200, LLCKNT2026-01-16
08015262035662NUTRIFITPENTAFERTE ITALIA SRLKNT2025-07-03
00860007229428QoraCM TECHNOLOGIES, INC.KNT2025-03-12
G461EGCT36M0EndolumikEndolumik, Inc.KNT2024-08-06
G461EGCT40M0EndolumikEndolumik, Inc.KNT2024-08-06
08015262022259VYGONVygon CorporationKNT2024-05-08
10192253007565ArgyleCardinal Health 200, LLCKNT2024-04-12
10192253007589ArgyleCardinal Health 200, LLCKNT2024-04-12
10192253007602ArgyleCardinal Health 200, LLCKNT2024-04-12
10192253007626ArgyleCardinal Health 200, LLCKNT2024-04-12
10192253007640ArgyleCardinal Health 200, LLCKNT2024-04-12
10192253007763ArgyleCardinal Health 200, LLCKNT2024-04-12
10192253007800KangarooCardinal Health 200, LLCKNT2024-04-12