COBRA-OS™ F01P1
GUDID 10628678061016
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| Primary Device ID | 10628678061016 |
| NIH Device Record Key | a679f892-ad68-47b3-90fc-ebc8923087dc |
| 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 |
| 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 | 10628678061016 [Primary] |
| GS1 | 16286780610016 [Previous] |
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 | 2023-09-04 |
| Device Publish Date | 2023-08-25 |
On-Brand Devices [COBRA-OS™]
| 16286780610009 | The COBRA-OS™ is intended for temporary occlusion of large vessels including patients requirin |
| 16286780610016 | The COBRA-OS™ is intended for temporary occlusion of large vessels including patients requirin |
| 10628678061016 | The COBRA-OS™ is intended for temporary occlusion of large vessels including patients requirin |
| 10628678061009 | The COBRA-OS™ is intended for temporary occlusion of large vessels including patients requirin |
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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