FDA.reportPublic FDA data

Exodus

Primary DI
H965105251
Brand
Exodus
Company
NAVILYST MEDICAL, INC.
Model
10525
Device description
Believe Biliary Drainage Catheter 8F x 35cm with Standard Pigtail
Published
2016-08-03
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
H965105251PackageHIBCC5In Commercial Distribution
H965105250PrimaryHIBCC0
15051684022705SecondaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1505168402270515051684022705

GMDN Terms#

Term, Definition table
TermDefinition
Biliary drainage catheterA flexible tube intended to be introduced percutaneously, for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. It is available in various designs, shapes, and sizes, and may include disposable devices dedicated to catheter introduction. This is a single-use device.

Device Sizes#

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

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
H787CT50LPBANFVI0BioFlo VortexCT50LPBANFVI2020-05-29
H787CT50LPBAVI0BioFlo VortexCT50LPBAVI2020-05-29
H787CT50LPBDNFVI0BioFlo VortexCT50LPBDNFVI2020-05-29
H787CT50LPBDVI0BioFlo VortexCT50LPBDVI2020-05-29
H787CT50LTBANFVI0BioFlo VortexCT50LTBANFVI2020-05-29
H787CT50LTBAVI0BioFlo VortexCT50LTBAVI2020-05-29
H787CT50LTBDNFVI0BioFlo VortexCT50LTBDNFVI2020-05-29
H787CT50LTBDVI0BioFlo VortexCT50LTBDVI2020-05-29
H787CT50PTBANFVI0BioFlo VortexCT50PTBANFVI2020-05-29
H787CT50PTBAVI0BioFlo VortexCT50PTBAVI2020-05-29
H787CT50PTBDNFVI0BioFlo VortexCT50PTBDNFVI2020-05-29
H787CT50PTBDVI0BioFlo VortexCT50PTBDVI2020-05-29
H787CT50STBDNFVI0BioFlo VortexCT50STBDNFVI2020-05-29
H787CT50STBDVI0BioFlo VortexCT50STBDVI2020-05-29
H787CT60LPBANFVI0BioFlo VortexCT60LPBANFVI2020-05-29
H787CT60LPBAVI0BioFlo VortexCT60LPBAVI2020-05-29
H787CT60LPBDNFVI0BioFlo VortexCT60LPBDNFVI2020-05-29
H787CT60LPBDVI0BioFlo VortexCT60LPBDVI2020-05-29
H787CT60LPPANFNV0BioFlo VortexCT60LPPANFNV2020-05-29
H787CT60LPPANFVI0BioFlo VortexCT60LPPANFVI2020-05-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
15711055100400M-DrainMermaid Medical A/SFGE2024-10-01
15711055110041M-DrainMermaid Medical A/SFGE2024-07-20
15711055110409M-DrainMermaid Medical A/SFGE2024-07-20
15711055120040M-DrainMermaid Medical A/SFGE2024-01-31
15711055120453M-DrainMermaid Medical A/SFGE2024-01-31
15711055000311M-DrainMermaid Medical A/SFGE2016-09-24
15711055000328M-DrainMermaid Medical A/SFGE2016-09-24
15711055000359M-DrainMermaid Medical A/SFGE2016-09-24
15711055000373M-DrainMermaid Medical A/SFGE2016-09-24
15711055000410M-DrainMermaid Medical A/SFGE2016-09-24
15711055000434M-DrainMermaid Medical A/SFGE2016-09-24
15711055000458M-DrainMermaid Medical A/SFGE2016-09-24
15711055000472M-DrainMermaid Medical A/SFGE2016-09-24
15711055000496M-DrainMermaid Medical A/SFGE2016-09-24
15711055000519M-DrainMermaid Medical A/SFGE2016-09-24
15711055000533M-DrainMermaid Medical A/SFGE2016-09-24
15711055000557M-DrainMermaid Medical A/SFGE2016-09-24
15711055000588M-DrainMermaid Medical A/SFGE2016-09-24
15711055000595M-DrainMermaid Medical A/SFGE2016-09-24
15711055000625M-DrainMermaid Medical A/SFGE2016-09-24
15711055000632M-DrainMermaid Medical A/SFGE2016-09-24
15711055000663M-DrainMermaid Medical A/SFGE2016-09-24
15711055000670M-DrainMermaid Medical A/SFGE2016-09-24
15711055000700M-DrainMermaid Medical A/SFGE2016-09-24
15711055000724M-DrainMermaid Medical A/SFGE2016-09-24
15711055000748M-DrainMermaid Medical A/SFGE2016-09-24
15711055000762M-DrainMermaid Medical A/SFGE2016-09-24
15711055000779M-DrainMermaid Medical A/SFGE2016-09-24
15711055000809M-DrainMermaid Medical A/SFGE2016-09-24
15711055000816M-DrainMermaid Medical A/SFGE2016-09-24