AngioDynamics
GUDID H787181002035
Percutaneous Introducer Sheath
ANGIODYNAMICS, INC.
Vascular catheter introduction set, nonimplantable| Primary Device ID | H787181002035 |
| NIH Device Record Key | 2a51fe91-c8ef-4ae2-b106-5be8fb9d28c8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AngioDynamics |
| Version Model Number | 18100203 |
| Company DUNS | 079105071 |
| Company Name | ANGIODYNAMICS, 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 |
Device Dimensions
| Catheter Gauge | 6 French |
| Catheter Gauge | 6 French |
| Catheter Gauge | 6 French |
| Catheter Gauge | 6 French |
| Catheter Gauge | 6 French |
| Catheter Gauge | 6 French |
| Catheter Gauge | 6 French |
| Catheter Gauge | 6 French |
| Catheter Gauge | 6 French |
| Catheter Gauge | 6 French |
| Catheter Gauge | 6 French |
| Catheter Gauge | 6 French |
| Catheter Gauge | 6 French |
| Catheter Gauge | 6 French |
| Catheter Gauge | 6 French |
| Catheter Gauge | 6 French |
| Catheter Gauge | 6 French |
| Catheter Gauge | 6 French |
Operating and Storage Conditions
| Storage Environment Temperature | Between 0 and 27 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 27 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 27 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 27 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 27 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 27 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 27 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 27 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 27 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 27 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 27 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 27 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 27 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 27 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 27 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 27 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 27 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 27 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 15051684018937 [Secondary] |
| HIBCC | H787181002030 [Primary] |
| HIBCC | H787181002035 [Package] Contains: H787181002030 Package: BOX [10 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K780126
FDA Product Code
| DRE | DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-06-07 |
| Device Publish Date | 2016-09-20 |
On-Brand Devices [AngioDynamics]
| H7877001057400 | Japanese Software Module for RITA Model 1500X RF Generator |
| H7877001049180 | Software Module for RITA Model 1500X RF Generator |
| H787565970035 | Standard Micro Introducer Kit |
| H787181002045 | Percutaneous Introducer Sheath |
| H787181002035 | Percutaneous Introducer Sheath |
| H787181002015 | Percutaneous Introducer Set |
| H787065972025 | Stainless Steel Guidewire w/ Tungsten Tip |
| H787065972015 | Nitinol Guidewire w/ Tungsten Tip |
| H787065971045 | Stiffened Micro Introducer |
| H787065971035 | Stiffened Micro Introducer |
| H787065971025 | Standard Micro Introducer |
| H787065971015 | Standard Micro Introducer |
| H787065970705 | Stiffened Micro Introducer Kit |
| H787065970695 | Stiffened Micro Introducer Kit |
| H787065970685 | Stiffened Micro Introducer Kit |
| H787065970675 | Stiffened Micro Introducer Kit |
| H787065970655 | Stiffened Micro Introducer Kit |
| H787065970625 | Stiffened Micro Introducer Kit |
| H787065970615 | Stiffened Micro Introducer Kit |
| H787065970605 | Stiffened Micro Introducer Kit |
| H787065970595 | Stiffened Micro Introducer Kit |
| H787065970585 | Stiffened Micro Introducer Kit |
| H787065970575 | Stiffened Micro Introducer Kit |
| H787065970565 | Stiffened Micro Introducer Kit |
| H787065970555 | Stiffened Micro Introducer Kit |
| H787065970545 | Stiffened Micro Introducer Kit |
| H787065970535 | Stiffened Micro Introducer Kit |
| H787065970525 | Stiffened Micro Introducer Kit |
| H787065970515 | Stiffened Micro Introducer Kit |
| H787065970505 | Stiffened Micro Introducer Kit |
| H787065970495 | Stiffened Micro Introducer Kit |
| H787065970485 | Stiffened Micro Introducer Kit |
| H787065970465 | Stiffened Micro Introducer Kit |
| H787065970415 | Stiffened Micro Introducer Kit |
| H787065970405 | Stiffened Micro Introducer Kit |
| H787065970395 | Stiffened Micro Introducer Kit |
| H787065970375 | Stiffened Micro Introducer Kit |
| H787065970355 | Standard Micro Introducer Kit |
| H787065970345 | Standard Micro Introducer Kit |
| H787065970335 | Standard Micro Introducer Kit |
| H787065970325 | Standard Micro Introducer Kit |
| H787065970315 | Standard Micro Introducer Kit |
| H787065970305 | Standard Micro Introducer Kit |
| H787065970295 | Standard Micro Introducer Kit |
| H787065970285 | Standard Micro Introducer Kit |
| H787065970275 | Standard Micro Introducer Kit |
| H787065970265 | Standard Micro Introducer Kit |
| H787065970255 | Standard Micro Introducer Kit |
| H787065970245 | Standard Micro Introducer Kit |
| H787065970225 | Standard Micro Introducer Kit |
Trademark Results [AngioDynamics]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ANGIODYNAMICS 87099675 5119513 Live/Registered |
AngioDynamics, Inc. 2016-07-11 |
 ANGIODYNAMICS 77786077 3749761 Live/Registered |
Angiodynamics, Inc. 2009-07-21 |
 ANGIODYNAMICS 76497558 2822666 Live/Registered |
AngioDynamics, Inc. 2003-03-17 |
 ANGIODYNAMICS 74255742 1804291 Dead/Cancelled |
ANGIODYNAMICS, INC. 1992-03-16 |
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