FDA.reportPublic FDA data

Peripheral Guidewire

Primary DI
10816349011235
Brand
Peripheral Guidewire
Company
BRIVANT LIMITED
Model
OEM BTK GW #4, 6G 300-014
Catalog number
901023-14
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
10816349011235PackageGS15In Commercial Distribution
00816349011238PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081634901123510816349011235
00816349011238008163490112388163490112380816349011238

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
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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07640142811886SET Rotarex™S 8 F x 110 cmStraub Medical AGDQX2022-05-04
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