FDA.reportPublic FDA data

Rapidwire

Primary DI
10816349011082
Brand
Rapidwire
Company
BRIVANT LIMITED
Model
RWIRE, ST, NOR, S, HY 300-014
Catalog number
1204-010-210
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
10816349011082PackageGS15In Commercial Distribution
00816349011085PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081634901108210816349011082
00816349011085008163490110858163490110850816349011085

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
00816349014888Hi-Torque Connect10125872026-04-24
00816349014895Hi-Torque Connect10125882026-04-24
00816349014901Hi-Torque Connect10125892026-04-24
00816349014918Hi-Torque Connect10125902026-04-27
00816349014925Hi-Torque Connect10125912026-04-27
00816349014932Hi-Torque Connect10125922026-04-27
00816349014949Hi-Torque Connect10125932026-04-27
00816349014956Hi-Torque Connect10125942026-04-27
00816349014963Hi-Torque Connect10125952026-04-27
00816349011597ExcursionEXCSN,MED,NOR,S,HY,FLT 195-0101622-000-0102017-11-08
00816349011603ExcursionEXCSN,STD,NOR,J,HY,FLT 195-0101623-001-0102017-11-08
00816349011610ExcursionEXCSN,FPY,NOR,S,HY,FLT 195-0101621-000-0102017-11-08
00816349010439Hydraview HVIEW GW, ES, S 190-014901021-012017-05-23
00816349010446Hydraview HVIEW GW, DS, S 190-014901021-022017-05-23
00816349010453Hydraview HVIEW GW, EDS, S TIP 190-014901021-032017-05-23
00816349010460Hydraview HVIEW GW, ES-J, J-TIP 190-014901021-042017-05-23
00816349010477Hydraview HVIEW GW, DS-J, J 190-014901021-052017-05-23
00816349010484Hydraview HVIEW GW, EDS-J, J 190-014901021-062017-05-23
00816349010880Flagship FSHP FLPY, XSUP, S, HY 195-0141601-100-011 2017-05-05
00816349010910Flagship FSHP, FLPY, NOR, S, HY 300-0141601-010-011 2017-04-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07649989542021SmartGUIDE deflectable hydrophilic guidewire Artiria Medical SADQX2026-03-02
07640142811305Guidewire 0.025 6/270cm angled Straub Medical AGDQX2022-06-30
07640142811312SET Aspirex™ S 6F 110cmStraub Medical AGDQX2022-06-30
07640142811329SET Aspirex™ S 6F 135cmStraub Medical AGDQX2022-06-30
07640142811336SET Aspirex™ S 8F 85cmStraub Medical AGDQX2022-06-30
07640142811343SET Aspirex™ S 8F 110cmStraub Medical AGDQX2022-06-30
07640142811350SET Aspirex™ S 10F 110cmStraub Medical AGDQX2022-06-30
07640142811855SET Rotarex™S 6 F x 110 cmStraub Medical AGDQX2022-05-04
07640142811862SET Rotarex™S 6 F x 135 cm Straub Medical AGDQX2022-05-04
07640142811879SET Rotarex™S 8 F x 85 cm Straub Medical AGDQX2022-05-04
07640142811886SET Rotarex™S 8 F x 110 cmStraub Medical AGDQX2022-05-04
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07640142810575SET Rotarex®S 6F 110cm (Straub Medical®)Straub Medical AGDQX2020-01-31
07640142810582SET Rotarex®S 6F 135cm (Straub Medical®)Straub Medical AGDQX2020-01-31
07640142810599SET Rotarex®S 8F 85cm (Straub Medical®)Straub Medical AGDQX2020-01-31
07640142810605SET Rotarex®S 8F 110 cm (Straub Medical®)Straub Medical AGDQX2020-01-31
07613327459647Synchro2Stryker CorporationDQX2019-06-20
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08714729327141Starter™ GuidewireLAKE REGION MEDICAL LIMITEDDQX2016-11-10