FDA.reportPublic FDA data

Exodus

Primary DI
H965105210
Brand
Exodus
Company
NAVILYST MEDICAL, INC.
Model
10521
Device description
Array Multipurpose Drainage Catheter 8F x 35cm with Tight Pigtail
Published
2016-08-05
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
FGECATHETER, BILIARY, DIAGNOSTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FGEStents, Drains And Dilators For The Biliary DuctsGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K152069000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152069000Exodus Array Multipurpose Drainage Catheter, Exodus Nuance Nephrostomy Drainage Catheter, Exodus Believe Biliary Drainage CatheterNavilyst Medical, Inc.2015-09-24FGE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
H965105211PackageHIBCC5In Commercial Distribution
H965105210PrimaryHIBCC0
15051684022675SecondaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1505168402267515051684022675

GMDN Terms#

Term, Definition table
TermDefinition
Closed-wound drain, non-bioabsorbableA tube-like, non-bioabsorbable device designed to establish a channel for the removal of fluid or purulent material from a closed-wound or an infected area, typically used with a closed drainage system that applies a low negative pressure through the drain lumen. It is typically made of silicone and comes in various designs/sizes for a variety of surgical applications (e.g., orthopaedic, plastic/reconstructive, neurological, gynaecological, thoracic, cardiovascular, general surgery). It might include disposable devices dedicated to drain insertion/function (e.g., sharp trocar blade, connector), however it does not include any fluid collection bags/containers. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge8French
Length35Centimeter
Outer Diameter2.7Millimeter

Contacts#

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

Regulatory Flags#

DUNS number
809699023
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
H787LG191005LifeguardLG-19-1002016-09-20
H787LG19755LifeguardLG-19-752016-09-20
H787LG201005LifeguardLG-20-1002016-09-20
H787LG201505LifeguardLG-20-1502016-09-20
H787LG20505LifeguardLG-20-502016-09-20
H787LG20755LifeguardLG-20-752016-09-20
H787LG221005LifeguardLG-22-1002016-09-20
H787LG22505LifeguardLG-22-502016-09-20
H787LG22755LifeguardLG-22-752016-09-20
H787LPS30045LifeportLPS 30042016-09-20
H787LPS30055LifeportLPS 30052016-09-20
H787LPS30065LifeportLPS 30062016-09-20
H787LPS30075LifeportLPS 30072016-09-20
H787LPS30085LifeportLPS 30082016-09-20
H787LPS30095LifeportLPS 30092016-09-20
H787LPS30175LifeportLPS 30172016-09-20
H787LPS30235LifeportLPS 30232016-09-20
H787LPS30255LifeportLPS 30252016-09-20
H787CT50LPBANFVI0BioFlo VortexCT50LPBANFVI2020-05-29
H787CT50LPBAVI0BioFlo VortexCT50LPBAVI2020-05-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06959664925645NAHangzhou AGS MedTech Co., Ltd.FGE2026-06-18
06959664925676NAHangzhou AGS MedTech Co., Ltd.FGE2026-06-18
06959664925584NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664925614NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664925959NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664925980NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664926017NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664926048NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664926314NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664926345NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664926376NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664926406NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664926673NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664926703NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664926734NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664926765NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664927038NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664927069NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664927090NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664927120NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664927403NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664927434NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664927465NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664927496NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664928943NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664928974NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664929001NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664929032NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664929070NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664929100NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15