FDA.reportPublic FDA data

Navylist

Primary DI
15051684023795
Brand
Navylist
Company
Angiodynamics, Inc.
Model
H965481080
Catalog number
48-108
Device description
GUIDEWIRE, 0.018 X 65CM Ni/Tu
Published
2024-10-18
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
DYBIntroducer, catheter
GAANEEDLE, ASPIRATION AND INJECTION, DISPOSABLE
GBXCATHETER, IRRIGATION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYBIntroducer, CatheterCardiovascular2
GAANeedle, Aspiration And Injection, DisposableGeneral, Plastic Surgery1
GBXCatheter, IrrigationGeneral, Plastic Surgery1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K170775000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170775000Mini Stick ENVI Non-Vascular Introducer KitAngioDynamics, Inc.2017-07-19DYB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
H965481080PreviousHIBCC0
15051684023795PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1505168402379515051684023795

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length65Centimeter
Outer Diameter0.018Inch

Contacts#

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

Regulatory Flags#

DUNS number
079252781
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
H787140650Syntrax Support Catheter14-0652021-11-02
H787140900Syntrax Support Catheter14-0902021-11-02
H787141350Syntrax Support Catheter14-1352021-11-02
H787141500Syntrax Support Catheter14-1502021-11-02
H787141800Syntrax Support Catheter14-1802021-11-02
H787180650Syntrax Support Catheter18-0652021-11-02
H787180900Syntrax Support Catheter18-0902021-11-02
H787181350Syntrax Support Catheter18-1352021-11-02
H787181500Syntrax Support Catheter18-1502021-11-02
H787181800Syntrax Support Catheter18-1802021-12-16
H787350650Syntrax Support Catheter35-0652021-11-02
H787350900Syntrax Support Catheter35-0902021-11-02
H787351350Syntrax Support Catheter35-1352021-11-02
H787351500Syntrax Support Catheter35-1502021-11-02
H787351801Syntrax Support Catheter35-1802021-11-02
15051684018777BioFloH96544027044-0272024-09-20
15051684018784BioFloH96544028044-0282024-09-20
05051684018473LifeportH787LPS30040LPS30042026-06-23
05051684018480LifeportH787LPS30050LPS30052026-06-23
05051684018497LifeportH787LPS30060LPS30062026-06-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956570955CARDINAL HEALTHCardinal Health 200, LLCGAA2026-09-04
00884450840597Prelude Roadster™Merit Medical Systems, Inc.DYB2026-08-27
06974949030920CorPassTM Introducer Sheath SetCardiocycle Medical (Suzhou) Co., LtdDYB2026-08-27
06974949030944CorPassTM Introducer Sheath SetCardiocycle Medical (Suzhou) Co., LtdDYB2026-08-27
10801902227246ARROWTELEFLEX INCORPORATEDDYB2026-08-27
10884450119836Prelude EASE™Merit Medical Systems, Inc.DYB2026-08-27
00884450834022MiniStop Plus™Merit Medical Systems, Inc.GAA2026-08-22
00884450681251Kensington™Merit Medical Systems, Inc.GAA2026-08-21
00884450681268Kensington™Merit Medical Systems, Inc.GAA2026-08-21
00884450681275Huntington™Merit Medical Systems, Inc.GAA2026-08-21
00884450681282Huntington™Merit Medical Systems, Inc.GAA2026-08-21
00884450681299Huntington™Merit Medical Systems, Inc.GAA2026-08-21
00884450681374Bedford™Merit Medical Systems, Inc.GAA2026-08-21
00884450838211Prelude Roadster™Merit Medical Systems, Inc.DYB2026-08-18
00199874352930Transseptal Puncture DevicePROTARYX MEDICAL INC.DYB2026-07-15
00198715836998EMPOWER™ INTRODUCER SHEATH WITH HYDROPHILIC COATINGFREUDENBERG MEDICAL, LLCDYB2026-01-29
00850291007260Intri24 Introducer SheathInari Medical, Inc.DYB2023-03-20
00886333003594Breast Localization NeedlesARGON MEDICAL DEVICES, INC.GAA2022-07-05
00886333003600Breast Localization NeedlesARGON MEDICAL DEVICES, INC.GAA2022-07-05
00886333003617Breast Localization NeedlesARGON MEDICAL DEVICES, INC.GAA2022-07-05
00886333003624Breast Localization NeedlesARGON MEDICAL DEVICES, INC.GAA2022-07-05
00886333003631Breast Localization NeedlesARGON MEDICAL DEVICES, INC.GAA2022-07-05
00886333007554Breast Localization NeedlesARGON MEDICAL DEVICES, INC.GAA2022-07-05
00886333007578Breast Localization NeedlesARGON MEDICAL DEVICES, INC.GAA2022-07-05
00886333007585Breast Localization NeedlesARGON MEDICAL DEVICES, INC.GAA2022-07-05
00886333007530Breast Localization NeedlesARGON MEDICAL DEVICES, INC.GAA2022-07-05
00886333007561Breast Localization NeedlesARGON MEDICAL DEVICES, INC.GAA2022-07-05
00886333003938Breast Localization NeedlesARGON MEDICAL DEVICES, INC.GAA2022-06-30
00886333007479Breast Localization NeedlesARGON MEDICAL DEVICES, INC.GAA2022-06-30
00886333007486Breast Localization NeedlesARGON MEDICAL DEVICES, INC.GAA2022-06-30