FDA.reportPublic FDA data

Rapidwire

Primary DI
10816349011099
Brand
Rapidwire
Company
BRIVANT LIMITED
Model
RWIRE, ST, NOR, S, HY 300-018
Catalog number
1214-010-210
Published
2017-05-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DQXWire, Guide, Catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQXWire, Guide, CatheterCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10816349011099PackageGS15In Commercial Distribution
00816349011092PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081634901109910816349011099
00816349011092008163490110928163490110920816349011092

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac/peripheral vascular guidewire, single-useA long, thin, sterile wire intended to be percutaneously placed into the cardiac vasculature (ventricles or coronary vessels) to function as a guide for the introduction, positioning, and/or operation of a device (e.g., catheter, pacing lead); it may also be used in the peripheral vasculature. It may be made of metal (e.g., stainless steel, Nitinol), or polymer and/or glass materials to provide MRI-compatibility, with or without coating, and is available in a variety of distal tip designs. It is used for various diagnostic and interventional procedures, and may include devices used to facilitate manipulation (e.g., torque device). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
985303473
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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
00816349014857ENROUTE 0.014" Guidewire901047-012024-12-03
00860009941304Aximed Prime Soft Shapeable Tip Vascular Guidewire901017- 01-AXI2023-06-27
00860009941311Aximed Prime Soft Shapeable Tip Vascular Guidewire901017- 03-AXI2023-06-27
00860009941328Aximed Prime Soft Shapeable Tip Vascular Guidewire901017- 09-AXI2023-06-27
00816349014154Charter Guidewire, 0.014", 180cm, Standard45-2812023-04-05
00816349014161Charter Guidewire, 0.018", 140cm, Standard45-2822023-04-05
00816349014178Charter Guidewire, 0.018", 180cm, Standard45-2832023-04-05
00816349014185Charter Guidewire, 0.014", 180cm, Soft45-2842023-04-05
00816349014192Charter Guidewire, 0.016", 180cm, Standard45-2852023-04-05
00816349014208Charter Guidewire, 0.016", 180cm, Soft45-2862023-04-05
00816349014215Charter Guidewire, 0.016", 300cm, Standard 45-2872023-04-05
00816349014222Charter Guidewire, 0.018", 180cm, Soft 45-2882023-04-05
00816349012358Victory ™Victory 18 (195 cm, 12g)H749394721951202021-12-15
00816349012365Victory ™Victory 18 (300 cm, 18g)H749394723001802021-12-15
00816349012372Victory ™Victory 14 (300 cm, 12g)H749394703001202021-12-15
00816349012389Victory ™Victory 14 (195 cm, 18g)H749394701951802021-12-15
00816349012396Victory ™Victory 18 (300 cm, 25g)H749394733002502021-12-15
00816349012402Victory ™Victory 14 (300 cm, 30g)H749394713003002021-12-15
00816349012419Victory ™Victory 14 (195 cm, 30g)H749394711953002021-12-15
00816349012426Victory ™Victory 18 (300 cm, 30g)H749394733003002021-12-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10816349013574GuideRightLake Region MedicalDQX2026-03-24
10816349013581GuideRightLake Region MedicalDQX2026-03-24
10816349013598GuideRightLake Region MedicalDQX2026-03-24
10816349013604GuideRightLake Region MedicalDQX2026-03-24
10816349013611GuideRightLake Region MedicalDQX2026-03-24
10816349013628GuideRightLake Region MedicalDQX2026-03-24
10816349013635GuideRightLake Region MedicalDQX2026-03-24
10816349013642GuideRightLake Region MedicalDQX2026-03-24
10816349013659GuideRightLake Region MedicalDQX2026-03-24
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