Valleylab
GUDID 20884521039015
Suction Coagulator
Covidien LP
Endoscopic electrosurgical handpiece/electrode, bipolar, single-use| Primary Device ID | 20884521039015 |
| NIH Device Record Key | d761881d-5187-425e-a6bc-3d60f12226ee |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Valleylab |
| Version Model Number | E2608-6 |
| 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 | false |
| 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 | |
| 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
| Length | 6 Inch |
| Catheter Gauge | 8 French |
| Length | 6 Inch |
| Catheter Gauge | 8 French |
| Length | 6 Inch |
| Catheter Gauge | 8 French |
| Length | 6 Inch |
| Catheter Gauge | 8 French |
| Length | 6 Inch |
| Catheter Gauge | 8 French |
| Length | 6 Inch |
| Catheter Gauge | 8 French |
| Length | 6 Inch |
| Catheter Gauge | 8 French |
| Length | 6 Inch |
| Catheter Gauge | 8 French |
| Length | 6 Inch |
| Catheter Gauge | 8 French |
| Length | 6 Inch |
| Catheter Gauge | 8 French |
| Length | 6 Inch |
| Catheter Gauge | 8 French |
| Length | 6 Inch |
| Catheter Gauge | 8 French |
| Length | 6 Inch |
| Catheter Gauge | 8 French |
| Length | 6 Inch |
| Catheter Gauge | 8 French |
| Length | 6 Inch |
| Catheter Gauge | 8 French |
| Length | 6 Inch |
| Catheter Gauge | 8 French |
| Length | 6 Inch |
| Catheter Gauge | 8 French |
| Length | 6 Inch |
| Catheter Gauge | 8 French |
| Length | 6 Inch |
| Catheter Gauge | 8 French |
| Length | 6 Inch |
| Catheter Gauge | 8 French |
| Length | 6 Inch |
| Catheter Gauge | 8 French |
| Length | 6 Inch |
| Catheter Gauge | 8 French |
| Length | 6 Inch |
| Catheter Gauge | 8 French |
| Length | 6 Inch |
| Catheter Gauge | 8 French |
| Length | 6 Inch |
| Catheter Gauge | 8 French |
| Length | 6 Inch |
| Catheter Gauge | 8 French |
| Length | 6 Inch |
| Catheter Gauge | 8 French |
| Length | 6 Inch |
| Catheter Gauge | 8 French |
| Length | 6 Inch |
| Catheter Gauge | 8 French |
| Length | 6 Inch |
| Catheter Gauge | 8 French |
| Length | 6 Inch |
| Catheter Gauge | 8 French |
Operating and Storage Conditions
| Handling Environment Temperature | Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Handling Environment Humidity | Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Handling Environment Humidity | Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Handling Environment Humidity | Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Handling Environment Humidity | Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Handling Environment Humidity | Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Handling Environment Humidity | Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Handling Environment Humidity | Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Handling Environment Humidity | Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Handling Environment Humidity | Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Handling Environment Humidity | Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Handling Environment Humidity | Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Handling Environment Humidity | Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Handling Environment Humidity | Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Handling Environment Humidity | Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Handling Environment Humidity | Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Handling Environment Humidity | Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Handling Environment Humidity | Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Handling Environment Humidity | Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Handling Environment Humidity | Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Handling Environment Humidity | Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Handling Environment Humidity | Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Handling Environment Humidity | Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Handling Environment Humidity | Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Handling Environment Humidity | Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Handling Environment Humidity | Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Handling Environment Humidity | Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Handling Environment Humidity | Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Handling Environment Humidity | Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Handling Environment Humidity | Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Handling Environment Humidity | Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Handling Environment Humidity | Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 20884521039015 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K791752
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 | 2 |
| Public Version Date | 2022-05-23 |
| Device Publish Date | 2020-06-05 |
On-Brand Devices [Valleylab]
| 20884524001002 | REM Polyhesive Adult Cordless Patient Return Electrode |
| 20884524000036 | Arthroscopic Pencil,Hook Electrode, Holster |
| 10884524001913 | Rocker Switch Pencil ERBE, Reusable |
| 10884524001821 | Tip Cleaner |
| 10884524001777 | Laparoscopic Monopolar Cord |
| 10884524001593 | Rocker Switch Pencil Reusable |
| 10884524001319 | Reliant Pencil,Erbe, Holster |
| 10884524000862 | Flexible Argon Electrode,Coagulation Only |
| 10884524000268 | Bipolar Forceps Cord,Banana Leads |
| 20884524000067 | Reliant Pencil,Holster |
| 10884521038950 | Suction Coagulator |
| 10884524002149 | Argon Tank Regulator |
| 10884521175631 | Blade Electrode;Caution: For manufacturing, processing, or repacking. |
| 10884524003658 | Rocker Switch Pencil |
| 10884524003641 | Rocker Switch Pencil,Holster |
| 10884524003634 | Rocker Switch Pencil,Holster |
| 10884524003627 | Rocker Switch Pencil,Holster |
| 10884524003610 | Rocker Switch Pencil,Needle Electrode, Holster |
| 10884524003603 | Rocker Switch Pencil |
| 10884524003597 | Rocker Switch Pencil,Holster, Smoke Attachment |
| 10884524003016 | Button Switch Pencil,Holster |
| 10884524002996 | Button Switch Pencil,Holster |
| 10884524002989 | Button Switch Pencil |
| 10884524002972 | Button Switch Pencil |
| 10884521039094 | Suction Coagulator |
| 10884521039070 | Suction Coagulator |
| 20884524002009 | Laparoscopic Curved Spatula Electrode,Solid |
| 30884524001993 | Laparoscopic Straight Spatula Electrode,Solid |
| 20884524001989 | Laparoscopic Flat L-Hook Electrode,Solid |
| 30884524001979 | Laparoscopic Wire L-Hook Electrode,Solid |
| 30884524001962 | Laparoscopic Wire L-Hook Electrode,Solid |
| 30884524001955 | Laparoscopic Wire J-Hook Electrode,Solid |
| 30884524001948 | Laparoscopic Curved Spatula Electrode,Solid |
| 10884521039018 | Suction Coagulator |
| 20884524001507 | Button Switch Pencil,Holster, Smoke Attachment |
| 20884524001491 | Rocker Switch Pencil,Holster, Smoke Attachment |
| 20884524000975 | Argon Tungsten Sharp Needle Electrode |
| 20884524000968 | Argon Handset |
| 20884524000920 | Laparoscopic Argon Blunt Needle Electrode,Retractable |
| 20884524000913 | Laparoscopic Argon Sharp Needle Electrode,Retractable |
| 20884524000906 | Laparoscopic Argon Blade Electrode,Retractable |
| 20884524000852 | Flexible Argon Electrode,Coagulation Only |
| 20884524000739 | Laparoscopic Flat L-Hook Electrode,Retractable, Aspiration Holes |
| 20884524000722 | Laparoscopic Wire L-Hook Electrode,Retractable, Aspiration Holes |
| 20884524000715 | Laparoscopic Wire J-Hook Electrode,Retractable, Aspiration Holes |
| 20884524000708 | Laparoscopic Curved Spatula Electrode,Retractable, Aspiration Holes |
| 20884524000593 | Button Switch Pencil,Needle Electrode, Holster |
| 30884524000583 | Laparoscopic Cylindrical Tip Electrode,Hollow |
| 20884524000579 | Laparoscopic Flat L-Hook Electrode,Hollow |
| 20884524000562 | Laparoscopic Wire L-Hook Electrode,Hollow |
Trademark Results [Valleylab]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 VALLEYLAB 73537355 1391496 Live/Registered |
VALLEYLAB, INC. 1985-05-13 |
 VALLEYLAB 73052165 1037361 Live/Registered |
VALLEYLAB, INC. 1975-05-12 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.