COBRA-OS® F01P1
GUDID 10628678061054
The COBRA-OS® is intended for temporary occlusion of large vessels including patients requiring emergency control of hemorrhage.
Front Line Medical Technologies Inc.
Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided| Primary Device ID | 10628678061054 |
| NIH Device Record Key | ad938e78-d7f7-4e27-9355-d1ccea75300f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | COBRA-OS® |
| Version Model Number | F01P1 |
| Catalog Number | F01P1 |
| Company DUNS | 242512799 |
| Company Name | Front Line Medical Technologies 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 |
Device Dimensions
| Length | 64.9 Centimeter |
| Balloon Catheter Tip Length | 6.4 Centimeter |
| Outer Diameter | 1.35 Millimeter |
| Balloon Diameter | 25 Millimeter |
| Catheter Working Length | 55 Centimeter |
| Length | 64.9 Centimeter |
| Balloon Catheter Tip Length | 6.4 Centimeter |
| Outer Diameter | 1.35 Millimeter |
| Balloon Diameter | 25 Millimeter |
| Catheter Working Length | 55 Centimeter |
| Length | 64.9 Centimeter |
| Balloon Catheter Tip Length | 6.4 Centimeter |
| Outer Diameter | 1.35 Millimeter |
| Balloon Diameter | 25 Millimeter |
| Catheter Working Length | 55 Centimeter |
| Length | 64.9 Centimeter |
| Balloon Catheter Tip Length | 6.4 Centimeter |
| Outer Diameter | 1.35 Millimeter |
| Balloon Diameter | 25 Millimeter |
| Catheter Working Length | 55 Centimeter |
| Length | 64.9 Centimeter |
| Balloon Catheter Tip Length | 6.4 Centimeter |
| Outer Diameter | 1.35 Millimeter |
| Balloon Diameter | 25 Millimeter |
| Catheter Working Length | 55 Centimeter |
| Length | 64.9 Centimeter |
| Balloon Catheter Tip Length | 6.4 Centimeter |
| Outer Diameter | 1.35 Millimeter |
| Balloon Diameter | 25 Millimeter |
| Catheter Working Length | 55 Centimeter |
| Length | 64.9 Centimeter |
| Balloon Catheter Tip Length | 6.4 Centimeter |
| Outer Diameter | 1.35 Millimeter |
| Balloon Diameter | 25 Millimeter |
| Catheter Working Length | 55 Centimeter |
| Length | 64.9 Centimeter |
| Balloon Catheter Tip Length | 6.4 Centimeter |
| Outer Diameter | 1.35 Millimeter |
| Balloon Diameter | 25 Millimeter |
| Catheter Working Length | 55 Centimeter |
| Length | 64.9 Centimeter |
| Balloon Catheter Tip Length | 6.4 Centimeter |
| Outer Diameter | 1.35 Millimeter |
| Balloon Diameter | 25 Millimeter |
| Catheter Working Length | 55 Centimeter |
| Length | 64.9 Centimeter |
| Balloon Catheter Tip Length | 6.4 Centimeter |
| Outer Diameter | 1.35 Millimeter |
| Balloon Diameter | 25 Millimeter |
| Catheter Working Length | 55 Centimeter |
| Length | 64.9 Centimeter |
| Balloon Catheter Tip Length | 6.4 Centimeter |
| Outer Diameter | 1.35 Millimeter |
| Balloon Diameter | 25 Millimeter |
| Catheter Working Length | 55 Centimeter |
| Length | 64.9 Centimeter |
| Balloon Catheter Tip Length | 6.4 Centimeter |
| Outer Diameter | 1.35 Millimeter |
| Balloon Diameter | 25 Millimeter |
| Catheter Working Length | 55 Centimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10628678061054 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K201652
FDA Product Code
| MJN | Catheter, Intravascular Occluding, Temporary |
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 | 2024-04-01 |
| Device Publish Date | 2024-03-22 |
Devices Manufactured by Front Line Medical Technologies Inc.
| 10628678061054 - COBRA-OS® | 2024-04-01The COBRA-OS® is intended for temporary occlusion of large vessels including patients requiring emergency control of hemorrhage. |
| 10628678061054 - COBRA-OS® | 2024-04-01 The COBRA-OS® is intended for temporary occlusion of large vessels including patients requiring emergency control of hemorrhage |
| 10628678061061 - Syringe, 10 mL | 2024-04-01 The Syringe, 10 mL is a component of the COBRA-OS™ Kit and is used to inflate the COBRA-OS™ balloon. |
| 10628678061009 - COBRA-OS™ | 2023-09-04 The COBRA-OS™ is intended for temporary occlusion of large vessels including patients requiring emergency control of hemorrhag |
| 10628678061016 - COBRA-OS™ | 2023-09-04 The COBRA-OS™ is intended for temporary occlusion of large vessels including patients requiring emergency control of hemorrhag |
| 10628678061023 - Syringe, 10 mL | 2023-09-04 The Syringe, 10 mL is a component of the COBRA-OS™ Kit and is used to inflate the COBRA-OS™ balloon. The COBRA-OS™ is inte |
| 16286780610016 - COBRA-OS™ | 2022-02-17 The COBRA-OS™ is intended for temporary occlusion of large vessels including patients requiring emergency control of hemorrhag |
| 16286780610023 - Syringe, 10 mL | 2022-02-17 The Syringe, 10 mL is a component of the COBRA-OS™ Kit and is used to inflate the COBRA-OS™ balloon. The COBRA-OS™ is inte |
| 16286780610009 - COBRA-OS™ | 2022-02-07 The COBRA-OS™ is intended for temporary occlusion of large vessels including patients requiring emergency control of hemorrhag |
Trademark Results [COBRA-OS]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 COBRA-OS 88721759 not registered Live/Pending |
FRONT LINE MEDICAL TECHNOLOGIES INC. 2019-12-10 |
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