Micro Access
GUDID H787065099225
Tearaway Introducer Kit
ANGIODYNAMICS, INC.
Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable| Primary Device ID | H787065099225 |
| NIH Device Record Key | 903b8236-a6f5-4d66-9413-086162237c1f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Micro Access |
| Version Model Number | 06509922 |
| 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 | |
| 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 | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 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 |
| 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 | 15051684012188 [Secondary] |
| HIBCC | H787065099220 [Primary] |
| HIBCC | H787065099225 [Package] Contains: H787065099220 Package: BOX [10 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K051655
FDA Product Code
| DYB | INTRODUCER, CATHETER |
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 [Micro Access]
| H787065110095 | Tearaway Introducer Set |
| H787065110085 | Tearaway Introducer Set |
| H787065110075 | Tearaway Introducer Set |
| H787065110065 | Tearaway Introducer Set |
| H787065110045 | Tearaway Introducer Set |
| H787065110035 | Tearaway Introducer Set |
| H787065099455 | Tearaway Introducer Kit |
| H787065099225 | Tearaway Introducer Kit |
| H787065099095 | Tearaway Introducer Kit |
| H787065086025 | Non-Echogenic Needle |
| H787065086015 | Echogenic Needle |
| H787065072045 | Stainless Steel Guidewire |
| H787065072035 | Nitinol Platinum Tip Guidewire |
| H787065072025 | Platinum Tip Guidewire |
| H787065072015 | Stainless Steel Guidewire |
| H787065068055 | B-Bevel Non-Echogenic Needle |
| H787065068045 | B-Bevel Non-Echogenic Needle |
| H787065068035 | B-Bevel Echogenic Needle |
| H787065068025 | B-Bevel Echogenic Needle |
| H787065068015 | A-Bevel Echogenic Needle |
Trademark Results [Micro Access]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MICRO ACCESS 76390367 not registered Dead/Abandoned |
Galt Medical Corporation 2002-04-01 |
 MICRO ACCESS 75463925 not registered Dead/Abandoned |
MICRO INNOVATIONS CORP. 1998-04-07 |
 MICRO ACCESS 74284979 2024766 Dead/Cancelled |
MicroAccess Computer Center, Inc. 1992-06-15 |
 MICRO ACCESS 74271289 not registered Dead/Abandoned |
Dynaflo Systems, Inc. 1992-05-01 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.