FDA.reportPublic FDA data

Peripheral Guidewire

Primary DI
10816349011129
Brand
Peripheral Guidewire
Company
BRIVANT LIMITED
Model
OEM BTK GW #1, 4G 195-018
Catalog number
901023-03
Published
2017-05-26
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
10816349011129PackageGS15In Commercial Distribution
00816349011122PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081634901112910816349011129
00816349011122008163490111228163490111220816349011122

GMDN Terms#

Term, Definition table
TermDefinition
Peripheral vascular guidewire, manualA long, thin, sterile wire intended to be percutaneously placed into the peripheral vasculature (not heart or central nervous system) to function as a guide for the introduction of devices (e.g., catheters). It is made of metal (e.g., stainless steel, Nitinol), with or without coating, and is available in a variety of distal tip designs. It is intended to be used for percutaneous angiography, angioplasty, rotational atherectomy and thrombectomy, drainage, and other diagnostic and interventional procedures. It 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
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
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
10816349013536GuideRightLake Region MedicalDQX2026-03-24
10816349013543GuideRightLake Region MedicalDQX2026-03-24
10816349013550GuideRightLake Region MedicalDQX2026-03-24
10816349013567GuideRightLake Region MedicalDQX2026-03-24
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
10816349013666GuideRightLake Region MedicalDQX2026-03-24
10884450529581SplashWire™Merit Medical Systems, Inc.DQX2026-03-24
20801902193418ARROWTELEFLEX INCORPORATEDDQX2026-03-23
20801902221876ARROWTELEFLEX INCORPORATEDDQX2026-03-13
20801902221883ARROWTELEFLEX INCORPORATEDDQX2026-03-13
20801902221890ARROWTELEFLEX INCORPORATEDDQX2026-03-13
20801902225522ARROWTELEFLEX INCORPORATEDDQX2026-03-11
16936733736408ULTRASKINLepu Medical Technology (Beijing) Co.,Ltd.DQX2026-02-27
16936733736415ULTRASKINLepu Medical Technology (Beijing) Co.,Ltd.DQX2026-02-27
16936733736644ULTRASKINLepu Medical Technology (Beijing) Co.,Ltd.DQX2026-02-27
16936733736651ULTRASKINLepu Medical Technology (Beijing) Co.,Ltd.DQX2026-02-27
16936733736668ULTRASKINLepu Medical Technology (Beijing) Co.,Ltd.DQX2026-02-27
06936733736678ULTRASKINLepu Medical Technology (Beijing) Co.,Ltd.DQX2026-02-27
16936733736965ULTRASKINLepu Medical Technology (Beijing) Co.,Ltd.DQX2026-02-27
16936733736996ULTRASKINLepu Medical Technology (Beijing) Co.,Ltd.DQX2026-02-27
16936733737009ULTRASKINLepu Medical Technology (Beijing) Co.,Ltd.DQX2026-02-27
16936733737085ULTRASKINLepu Medical Technology (Beijing) Co.,Ltd.DQX2026-02-27