Exodus
- Primary DI
- H965105240
- Brand
- Exodus
- Company
- NAVILYST MEDICAL, INC.
- Model
- 10524
- Device description
- Nuance Nephrostomy Drainage Catheter 14F 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
- Sterile
- true
- Single use
- true
Contact Domains#
angiodynamics.comProduct Codes#
| Code | Name |
|---|---|
| FGE | CATHETER, BILIARY, DIAGNOSTIC |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| FGE | Stents, Drains And Dilators For The Biliary Ducts | Gastroenterology, Urology | 2 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K152069 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| H965105241 | Package | HIBCC | 5 | In Commercial Distribution |
| H965105240 | Primary | HIBCC | 0 | |
| 15051684022699 | Secondary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized |
|---|---|
| 15051684022699 | 15051684022699 |
GMDN Terms#
| Term | Definition |
|---|---|
| Nephrostomy catheter | A sterile, flexible tube intended to be inserted percutaneously into the renal pelvis to gain access to the upper urinary tract. This device consists of a large-bore (sizes from 14 to 24 Fr are typical), thin-walled tube usually with a self-retained tip; it sometimes has expanding wings on its tip. It is used to perform drainage for relief of supravesicular obstructions and may also be intended for a variety of procedures of the upper urinary tract including dilation of strictures, removal of calculi, perfusion with chemolytic agents for dissolution of renal stones, or ureteral stenting. This is a single-use device. |
Device Sizes#
| Type | Value | Unit |
|---|---|---|
| Catheter Gauge | 14 | French |
| Length | 35 | Centimeter |
| Outer Diameter | 4.7 | Millimeter |
Contacts#
| Phone | |
|---|---|
| +1(518)795-1676 | dgreer@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 | Catalog | Published |
|---|---|---|---|---|
| H787LG191005 | Lifeguard | LG-19-100 | 2016-09-20 | |
| H787LG19755 | Lifeguard | LG-19-75 | 2016-09-20 | |
| H787LG201005 | Lifeguard | LG-20-100 | 2016-09-20 | |
| H787LG201505 | Lifeguard | LG-20-150 | 2016-09-20 | |
| H787LG20505 | Lifeguard | LG-20-50 | 2016-09-20 | |
| H787LG20755 | Lifeguard | LG-20-75 | 2016-09-20 | |
| H787LG221005 | Lifeguard | LG-22-100 | 2016-09-20 | |
| H787LG22505 | Lifeguard | LG-22-50 | 2016-09-20 | |
| H787LG22755 | Lifeguard | LG-22-75 | 2016-09-20 | |
| H787LPS30045 | Lifeport | LPS 3004 | 2016-09-20 | |
| H787LPS30055 | Lifeport | LPS 3005 | 2016-09-20 | |
| H787LPS30065 | Lifeport | LPS 3006 | 2016-09-20 | |
| H787LPS30075 | Lifeport | LPS 3007 | 2016-09-20 | |
| H787LPS30085 | Lifeport | LPS 3008 | 2016-09-20 | |
| H787LPS30095 | Lifeport | LPS 3009 | 2016-09-20 | |
| H787LPS30175 | Lifeport | LPS 3017 | 2016-09-20 | |
| H787LPS30235 | Lifeport | LPS 3023 | 2016-09-20 | |
| H787LPS30255 | Lifeport | LPS 3025 | 2016-09-20 | |
| H787CT50LPBANFVI0 | BioFlo Vortex | CT50LPBANFVI | 2020-05-29 | |
| H787CT50LPBAVI0 | BioFlo Vortex | CT50LPBAVI | 2020-05-29 |
Other Devices Sharing Product Codes#
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|---|---|---|---|---|
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| 15711055000373 | M-Drain | Mermaid Medical A/S | FGE | 2016-09-24 |
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| 15711055000588 | M-Drain | Mermaid Medical A/S | FGE | 2016-09-24 |
| 15711055000595 | M-Drain | Mermaid Medical A/S | FGE | 2016-09-24 |
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| 15711055000632 | M-Drain | Mermaid Medical A/S | FGE | 2016-09-24 |
| 15711055000663 | M-Drain | Mermaid Medical A/S | FGE | 2016-09-24 |
| 15711055000670 | M-Drain | Mermaid Medical A/S | FGE | 2016-09-24 |
| 15711055000700 | M-Drain | Mermaid Medical A/S | FGE | 2016-09-24 |
| 15711055000724 | M-Drain | Mermaid Medical A/S | FGE | 2016-09-24 |
| 15711055000748 | M-Drain | Mermaid Medical A/S | FGE | 2016-09-24 |
| 15711055000762 | M-Drain | Mermaid Medical A/S | FGE | 2016-09-24 |
| 15711055000779 | M-Drain | Mermaid Medical A/S | FGE | 2016-09-24 |
| 15711055000809 | M-Drain | Mermaid Medical A/S | FGE | 2016-09-24 |
| 15711055000816 | M-Drain | Mermaid Medical A/S | FGE | 2016-09-24 |