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
| 10884521581876 - Barrx | 2024-11-15 360 Express RFA Balloon Catheter |
| 10884521581753 - Barrx | 2024-11-12 Channel RFA Endoscopic Catheter Esophageal TTS, 120 Applications |
| 10884521581821 - Barrx | 2024-11-12 90 RFA Focal Catheter Chang Cap, 80 Applications |
| 10884521581838 - Barrx | 2024-11-12 Ultra Long RFA Focal Catheter 80 Applications |
| 10884521581845 - Barrx | 2024-11-12 60 RFA Focal Catheter 80 Applications |
| 20884521811130 - Ritus | 2024-10-29 Peritoneal Dialysis Accessory Beta-Cap Adapter |
| 20884521811208 - Ritus | 2024-10-29 Peritoneal Dialysis Accessory Blunt Tunneling Stylet |
| 10884521811225 - Ritus | 2024-10-29 Peritoneal Dialysis Accessory Two Part Titanium Luer Adapter |
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 |
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