FDA.reportPublic FDA data

Exodus

Primary DI
H965105121
Brand
Exodus
Company
NAVILYST MEDICAL, INC.
Model
10512
Device description
Array Multipurpose Drainage Catheter 10F 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
OTC
false
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
H965105121PackageHIBCC5In Commercial Distribution
H965105120PrimaryHIBCC0
15051684022620SecondaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1505168402262015051684022620

GMDN Terms#

Term, Definition table
TermDefinition
Closed-wound drainA sterile, tube-like 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 wide variety of surgical applications (e.g., orthopaedic, plastic/reconstructive, neurological, gynaecological, thoracic, cardiovascular, and general surgery). It might include disposable devices dedicated to drain insertion/function (e.g., sharp metal trocar, 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 Gauge10French
Length35Centimeter
Outer Diameter3.4Millimeter

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
809699023
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
H787471430Celerity47-1432015-10-19
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

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00850078427496ARCHIMEDES Biodegradable StentQ3 Medical USA LLCFGE2026-09-18
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04052838002424Endoflux™Medi-Globe GmbHFGE2026-08-27
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