ClosureRFS
GUDID 10884521058095
Endovenous Radiofrequency Stylet,6 Fr/Ch (2.0 mm) x 12 cm
Covidien LP
Peripheral vascular electrocautery catheter, single-use| Primary Device ID | 10884521058095 |
| NIH Device Record Key | 072dcd15-f2ff-430a-8c33-0f544761eca5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ClosureRFS |
| Version Model Number | RFS2-6-12 |
| Company DUNS | 058614483 |
| Company Name | Covidien LP |
| 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com |
Device Dimensions
| Catheter Gauge | 6 French |
| Length | 12 Centimeter |
| Catheter Gauge | 6 French |
| Length | 12 Centimeter |
| Catheter Gauge | 6 French |
| Length | 12 Centimeter |
| Catheter Gauge | 6 French |
| Length | 12 Centimeter |
| Catheter Gauge | 6 French |
| Length | 12 Centimeter |
| Catheter Gauge | 6 French |
| Length | 12 Centimeter |
| Catheter Gauge | 6 French |
| Length | 12 Centimeter |
| Catheter Gauge | 6 French |
| Length | 12 Centimeter |
| Catheter Gauge | 6 French |
| Length | 12 Centimeter |
| Catheter Gauge | 6 French |
| Length | 12 Centimeter |
| Catheter Gauge | 6 French |
| Length | 12 Centimeter |
| Catheter Gauge | 6 French |
| Length | 12 Centimeter |
| Catheter Gauge | 6 French |
| Length | 12 Centimeter |
| Catheter Gauge | 6 French |
| Length | 12 Centimeter |
| Catheter Gauge | 6 French |
| Length | 12 Centimeter |
| Catheter Gauge | 6 French |
| Length | 12 Centimeter |
| Catheter Gauge | 6 French |
| Length | 12 Centimeter |
Operating and Storage Conditions
| Handling Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10884521058095 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K052003
FDA Product Code
| GEI | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2024-02-07 |
| Device Publish Date | 2016-09-24 |
Devices Manufactured by Covidien LP
| 20884521703732 - Tri-Staple 2.0 | 2024-12-09 Black Extra Thick Circular Reload For use with Signia Circular Adapters |
| 20884521703756 - Tri-Staple 2.0 | 2024-12-09 Black Extra Thick Circular Reload For use with Signia Circular Adapters |
| 20884521703770 - Tri-Staple 2.0 | 2024-12-09 Black Extra Thick Circular Reload For use with Signia Circular Adapters |
| 20884521822891 - DAR | 2024-12-09 Closed Suction System, Replaceable Catheter Endotracheal Length |
| 10884521845480 - Signia | 2024-12-09 SIGNIA CIRCULAR ADAPTER STND LENGTH FT |
| 10884521845497 - Signia | 2024-12-09 SIGNIA CIRCULAR ADAPTER XL LENGTH FT |
| 20884521581859 - Barrx | 2024-11-18 RFA Cleaning Cap Small |
| 20884521581866 - Barrx | 2024-11-18 RFA Cleaning Cap Medium |
Trademark Results [ClosureRFS]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CLOSURERFS 78981242 3738308 Live/Registered |
COVIDIEN LP 2005-11-15 |
 CLOSURERFS 78754642 not registered Dead/Abandoned |
VNUS Medical Technologies, Inc. 2005-11-15 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.