Exodus
- Primary DI
- H965105270
- Brand
- Exodus
- Company
- NAVILYST MEDICAL, INC.
- Model
- 10527
- Device description
- Believe Biliary Drainage Catheter 12F 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 |
|---|---|---|---|---|
| H965105271 | Package | HIBCC | 5 | In Commercial Distribution |
| H965105270 | Primary | HIBCC | 0 | |
| 15051684022729 | Secondary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized |
|---|---|
| 15051684022729 | 15051684022729 |
GMDN Terms#
| Term | Definition |
|---|---|
| Biliary drain | A flexible tube intended for percutaneous placement in the abdomen to establish a channel for temporary or prolonged drainage of an obstructed biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. It is distally inserted into the common bile duct, hepatic ducts (transhepatic biliary drainage), or gallbladder (cholecystostomy drainage); disposable devices dedicated to drain introduction may be included with the device. It may be used in conjunction with a low negative pressure system and is available in various designs (e.g., silicone Y- or T-tube, catheter-like, with perforations). This is a single-use device. |
Device Sizes#
| Type | Value | Unit |
|---|---|---|
| Catheter Gauge | 12 | French |
| Length | 35 | Centimeter |
| Outer Diameter | 4 | 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 |
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| 15711055000588 | 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 |
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| 15711055000816 | M-Drain | Mermaid Medical A/S | FGE | 2016-09-24 |