FDA.reportPublic FDA data

ADx Guidewire

Primary DI
15051684019132
Brand
ADx Guidewire
Company
Angiodynamics, Inc.
Model
H7878105382600
Catalog number
810538260
Device description
GUIDEWIRE, PTFE 038 X 260CM FC 3MM J
Published
2024-11-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

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
25051684019139PackageGS110In Commercial Distribution
H7878105382601PackageHIBCC10In Commercial Distribution
H7878105382600PrimaryHIBCC0
15051684019132SecondaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2505168401913925051684019139
1505168401913215051684019132

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Length260Centimeter
Outer Diameter0.038Inch

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(518)795-1676dgreer@angiodynamics.com
+1(800)772-6446customerservice@angiodynamics.com

Regulatory Flags#

DUNS number
079252781
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
15051684023801Uni-Fuse+H787124018450124018452024-08-01
15051684023825Uni-Fuse+H787124018480124018482024-08-01
15051684023832Uni-Fuse+H787124018490124018492024-08-01
15051684023849Uni-Fuse+H787124018510124018512024-08-01
15051684023863Uni-Fuse+H787124018540124018542024-08-01
15051684023870Uni-Fuse+H787124018550124018552024-08-01
15051684023887Uni-Fuse+H787124018570124018572024-08-01
15051684023894Uni-Fuse+H787124018580124018582024-08-01
15051684023900Uni-Fuse+H787124018590124018592024-08-01
15051684023924Uni-Fuse+H787124018610124018612024-08-01
15051684023931Uni-Fuse+H787124018620124018622024-08-01
15051684023948Uni-Fuse+H787124018630124018632024-08-01
15051684030069NanoKnifeH78720300351US020300351US2026-05-04
15051684013727NanoKnifeH78720300301US020300301US2026-04-30
15051684017930NanoKnifeH787204001090204001092026-04-30
15051684017947NanoKnifeH787204001100204001102026-04-30
15051684017954NanoKnifeH787204003010204003012026-04-30
15051684029643NanoKnifeH787204001110204001112026-04-30
H787204001110NanoKnife204001112022-10-07
H787204003010NanoKnife204003012016-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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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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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08498840011904VYGONVygon CorporationDQX2019-04-05
08498840011928VYGONVygon CorporationDQX2019-04-05
08714729327141Starter™ GuidewireLAKE REGION MEDICAL LIMITEDDQX2016-11-10