Exodus
GUDID H965105801
Array Multipurpose Drainage Catheter 8F x 35cm with Standard Pigtail
NAVILYST MEDICAL, INC.
Closed-wound drain| Primary Device ID | H965105801 |
| NIH Device Record Key | ffd39755-1946-4880-b4f7-7eadb2e35a5a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Exodus |
| Version Model Number | 10580 |
| Company DUNS | 809699023 |
| Company Name | NAVILYST MEDICAL, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com |
Device Dimensions
| Outer Diameter | 2.7 Millimeter |
| Catheter Gauge | 8 French |
| Length | 35 Centimeter |
| Outer Diameter | 2.7 Millimeter |
| Catheter Gauge | 8 French |
| Length | 35 Centimeter |
| Outer Diameter | 2.7 Millimeter |
| Catheter Gauge | 8 French |
| Length | 35 Centimeter |
| Outer Diameter | 2.7 Millimeter |
| Catheter Gauge | 8 French |
| Length | 35 Centimeter |
| Outer Diameter | 2.7 Millimeter |
| Catheter Gauge | 8 French |
| Length | 35 Centimeter |
| Outer Diameter | 2.7 Millimeter |
| Catheter Gauge | 8 French |
| Length | 35 Centimeter |
| Outer Diameter | 2.7 Millimeter |
| Catheter Gauge | 8 French |
| Length | 35 Centimeter |
| Outer Diameter | 2.7 Millimeter |
| Catheter Gauge | 8 French |
| Length | 35 Centimeter |
| Outer Diameter | 2.7 Millimeter |
| Catheter Gauge | 8 French |
| Length | 35 Centimeter |
| Outer Diameter | 2.7 Millimeter |
| Catheter Gauge | 8 French |
| Length | 35 Centimeter |
| Outer Diameter | 2.7 Millimeter |
| Catheter Gauge | 8 French |
| Length | 35 Centimeter |
| Outer Diameter | 2.7 Millimeter |
| Catheter Gauge | 8 French |
| Length | 35 Centimeter |
| Outer Diameter | 2.7 Millimeter |
| Catheter Gauge | 8 French |
| Length | 35 Centimeter |
| Outer Diameter | 2.7 Millimeter |
| Catheter Gauge | 8 French |
| Length | 35 Centimeter |
| Outer Diameter | 2.7 Millimeter |
| Catheter Gauge | 8 French |
| Length | 35 Centimeter |
| Outer Diameter | 2.7 Millimeter |
| Catheter Gauge | 8 French |
| Length | 35 Centimeter |
| Outer Diameter | 2.7 Millimeter |
| Catheter Gauge | 8 French |
| Length | 35 Centimeter |
| Outer Diameter | 2.7 Millimeter |
| Catheter Gauge | 8 French |
| Length | 35 Centimeter |
| Outer Diameter | 2.7 Millimeter |
| Catheter Gauge | 8 French |
| Length | 35 Centimeter |
| Outer Diameter | 2.7 Millimeter |
| Catheter Gauge | 8 French |
| Length | 35 Centimeter |
| Outer Diameter | 2.7 Millimeter |
| Catheter Gauge | 8 French |
| Length | 35 Centimeter |
| Outer Diameter | 2.7 Millimeter |
| Catheter Gauge | 8 French |
| Length | 35 Centimeter |
| Outer Diameter | 2.7 Millimeter |
| Catheter Gauge | 8 French |
| Length | 35 Centimeter |
| Outer Diameter | 2.7 Millimeter |
| Catheter Gauge | 8 French |
| Length | 35 Centimeter |
| Outer Diameter | 2.7 Millimeter |
| Catheter Gauge | 8 French |
| Length | 35 Centimeter |
| Outer Diameter | 2.7 Millimeter |
| Catheter Gauge | 8 French |
| Length | 35 Centimeter |
| Outer Diameter | 2.7 Millimeter |
| Catheter Gauge | 8 French |
| Length | 35 Centimeter |
| Outer Diameter | 2.7 Millimeter |
| Catheter Gauge | 8 French |
| Length | 35 Centimeter |
| Outer Diameter | 2.7 Millimeter |
| Catheter Gauge | 8 French |
| Length | 35 Centimeter |
| Outer Diameter | 2.7 Millimeter |
| Catheter Gauge | 8 French |
| Length | 35 Centimeter |
| Outer Diameter | 2.7 Millimeter |
| Catheter Gauge | 8 French |
| Length | 35 Centimeter |
| Outer Diameter | 2.7 Millimeter |
| Catheter Gauge | 8 French |
| Length | 35 Centimeter |
| Outer Diameter | 2.7 Millimeter |
| Catheter Gauge | 8 French |
| Length | 35 Centimeter |
| Outer Diameter | 2.7 Millimeter |
| Catheter Gauge | 8 French |
| Length | 35 Centimeter |
| Outer Diameter | 2.7 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 15051684022842 [Secondary] |
| HIBCC | H965105800 [Primary] |
| HIBCC | H965105801 [Package] Contains: H965105800 Package: BOX [5 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K152069
FDA Product Code
| FGE | CATHETER, BILIARY, DIAGNOSTIC |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-08-05 |
On-Brand Devices [Exodus]
| H965105901 | Array Multipurpose Drainage Catheter 8F x 35cm with Tight Pigtail |
| H965105811 | Array Multipurpose Drainage Catheter 10F x 35cm with Tight Pigtail |
| H965105801 | Array Multipurpose Drainage Catheter 8F x 35cm with Standard Pigtail |
| H965105721 | Array Multipurpose Drainage Catheter 14F x 35cm with Standard Pigtail |
| H965105711 | Array Multipurpose Drainage Catheter 10F x 35cm with Standard Pigtail |
| H965105621 | Array Multipurpose Drainage Catheter 14F x 25cm with Standard Pigtail |
| H965105501 | Array Multipurpose Drainage Catheter 8F x 25cm with Tight Pigtail |
| H965105411 | Array Multipurpose Drainage Catheter 10F x 25cm with Tight Pigtail |
| H965105401 | Array Multipurpose Drainage Catheter 8F x 25cm with Standard Pigtail |
| H965105321 | Array Multipurpose Drainage Catheter 12F x 35cm with Standard Pigtail |
| H965105311 | Array Multipurpose Drainage Catheter 10F x 25cm with Standard Pigtail |
| H965105301 | Array Multipurpose Drainage Catheter 6F x 25cm with Tight Pigtail |
| H965105291 | Nuance Nephrostomy Drainage Catheter 12F x 35cm with Tight Pigtail |
| H965105281 | Believe Biliary Drainage Catheter 14F x 35cm with Standard Pigtail |
| H965105271 | Believe Biliary Drainage Catheter 12F x 35cm with Standard Pigtail |
| H965105261 | Believe Biliary Drainage Catheter 10F x 35cm with Standard Pigtail |
| H965105251 | Believe Biliary Drainage Catheter 8F x 35cm with Standard Pigtail |
| H965105241 | Nuance Nephrostomy Drainage Catheter 14F x 35cm with Tight Pigtail |
| H965105221 | Array Multipurpose Drainage Catheter 12F x 25cm with Standard Pigtail |
| H965105211 | Array Multipurpose Drainage Catheter 8F x 35cm with Tight Pigtail |
| H965105201 | Array Multipurpose Drainage Catheter 6F x 15cm with Tight Pigtail |
| H965105181 | Nuance Nephrostomy Drainage Catheter 10F x 25cm with Tight Pigtail |
| H965105161 | Nuance Nephrostomy Drainage Catheter 8F x 35cm with Tight Pigtail |
| H965105141 | Nuance Nephrostomy Drainage Catheter 6F x 25cm with Tight Pigtail |
| H965105121 | Array Multipurpose Drainage Catheter 10F x 35cm with Tight Pigtail |
| H965105101 | Array Multipurpose Drainage Catheter 6F x 25cm with Tight Pigtail |
| H965104361 | Array Multipurpose Drainage Catheter 14F x 35cm with Standard Pigtail |
| H965104341 | Array Multipurpose Drainage Catheter 12F x 35cm with Standard Pigtail |
| H965104281 | Nuance Nephrostomy Drainage Catheter 14F x 25cm with Standard Pigtail |
| H965104271 | Array Multipurpose Drainage Catheter 14F x 25cm with Standard Pigtail |
| H965104261 | 14F x 25cm J-Tip Multipurpose Drainage Catheter with GLYCE Hydrophilic Coating |
| H965104241 | Nuance Nephrostomy Drainage Catheter 12F x 25cm with Tight Pigtail |
| H965104231 | Array Multipurpose Drainage Catheter 12F x 25cm with Standard Pigtail |
| H965104221 | 12F x 25cm J-Tip Multipurpose Drainage Catheter with GLYCE Hydrophilic Coating |
| H965104151 | 10F x 25cm Standard Loop Nephrostomy Drainage Catheter with GLYCE Hydrophilic Coating |
| H965104121 | Nuance Nephrostomy Drainage Catheter 10F x 25cm with Tight Pigtail |
| H965104111 | Array Multipurpose Drainage Catheter 10F x 25cm with Tight Pigtail |
| H965104081 | 10F x 20cm J-Tip Multipurpose Drainage Catheter with GLYCE Hydrophilic Coating |
| H965104071 | Nuance Nephrostomy Drainage Catheter 8F x 25cm with Tight Pigtail |
| H965104041 | 8F x 25cm Standard Loop Nephrostomy Drainage Catheter with GLYCE Hydrophilic Coating |
| H965104031 | Array Multipurpose Drainage Catheter 8F x 25cm with Tight Pigtail |
| H965104011 | 8F x 20cm J-Tip Multipurpose Drainage Catheter with GLYCE Hydrophilic Coating |
| H965101511 | Array Multipurpose Drainage Catheter 10F x 25cm with Standard Pigtail |
| H965101431 | Array Multipurpose Drainage Catheter 8F x 25cm with Standard Pigtail |
| H965100521 | Array Multipurpose Drainage Catheter 10F x 35cm with Standard Pigtail |
| H965100441 | Array Multipurpose Drainage Catheter 8F x 35cm with Standard Pigtail |
| H965100321 | 10F x 35cm Standard Loop Multipurpose Drainage Catheter with GLYCE Hydrophilic Coating |
| H965100081 | 10F x 20cm J-Tip Multipurpose Drainage Catheter with GLYCE Hydrophilic Coating |
| H965100031 | 8F x 25cm Tight Loop Multipurpose Drainage Catheter with GLYCE Hydrophilic Coating |
| H965100021 | 8F x 25cm Standard Loop Multipurpose Drainage Catheter with GLYCE Hydrophilic Coating |
Trademark Results [Exodus]
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