Intara™ Introducer Sheath ISD10040
GUDID 20886333227598
Intara™ Introducer Sheath 10F x 41.5cm
ARGON MEDICAL DEVICES, 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| Primary Device ID | 20886333227598 |
| NIH Device Record Key | 2165fdef-7774-467c-beef-c3d172c4c366 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Intara™ Introducer Sheath |
| Version Model Number | ISD10040 |
| Catalog Number | ISD10040 |
| Company DUNS | 140727624 |
| Company Name | ARGON MEDICAL DEVICES, 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 | true |
| 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
Device Dimensions
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry and away from sunlight |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00886333227594 [Primary] |
| GS1 | 20886333227598 [Package] Contains: 00886333227594 Package: Box [5 Units] In Commercial Distribution |
FDA Product Code
| DYB | Introducer, Catheter |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-06-21 |
| Device Publish Date | 2024-06-13 |
Devices Manufactured by ARGON MEDICAL DEVICES, INC.
| 20886333227598 - Intara™ Introducer Sheath | 2024-06-21Intara™ Introducer Sheath 10F x 41.5cm |
| 20886333227598 - Intara™ Introducer Sheath | 2024-06-21 Intara™ Introducer Sheath 10F x 41.5cm |
| 00886333227167 - CLEANER Vac™ | 2024-04-25 CLEANER Vac™ Thrombectomy System - 18F OD x 115cm |
| 00886333227174 - Cleaner Vac™ | 2024-04-25 Cleaner Vac™ - 18F OD x 115cm Aspiration Catheter with Handpiece |
| 00886333227624 - Cleaner Vac™ | 2024-04-25 Cleaner Vac™ Aspiration Canister |
| 00886333225743 - Kodiak | 2023-07-10 Kodiak™ Dual Port Coaxial Introducer Kit |
| 20886333227284 - Co-Axial Introducer Needle | 2023-06-16 Co-Axial Introducer Needle 15ga x 6.8cm |
| 20886333227383 - Percutaneous Introducer | 2023-04-19 Percutaneous Introducer with Depth Marks 4F x 25cm |
| 20886333227390 - Percutaneous Introducer | 2023-04-19 Percutaneous Introducer with Depth Marks 4F x 45cm |
Trademark Results [Intara]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 INTARA 98389320 not registered Live/Pending |
Argon Medical Devices, Inc. 2024-02-02 |
 INTARA 79077103 3903163 Dead/Cancelled |
B÷RO GmbH & Co.KG 2009-11-06 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.