Valleylab E2515HGNSB
GUDID 10884524003634
Rocker Switch Pencil,Holster
Covidien LP
Endoscopic electrosurgical handpiece/electrode, bipolar, single-use| Primary Device ID | 10884524003634 |
| NIH Device Record Key | b8b2e580-74eb-4b2f-a284-f95ffddae011 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Valleylab |
| Version Model Number | E2515HGNSB |
| Catalog Number | E2515HGNSB |
| Company DUNS | 058614483 |
| Company Name | Covidien LP |
| Device Count | 1800 |
| 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 | false |
| 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 |
Device Dimensions
| Length | 10 Feet |
| Length | 10 Feet |
| Length | 10 Feet |
| Length | 10 Feet |
| Length | 10 Feet |
| Length | 10 Feet |
| Length | 10 Feet |
| Length | 10 Feet |
| Length | 10 Feet |
| Length | 10 Feet |
| Length | 10 Feet |
| Length | 10 Feet |
| Length | 10 Feet |
| Length | 10 Feet |
Operating and Storage Conditions
| Handling Environment Temperature | Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10884524003634 [Primary] |
| GS1 | 20884524003631 [Unit of Use] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K813071
FDA Product Code
| GEI | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
[10884524003634]
Radiation Sterilization
[10884524003634]
Radiation Sterilization
[10884524003634]
Radiation Sterilization
[10884524003634]
Radiation Sterilization
[10884524003634]
Radiation Sterilization
[10884524003634]
Radiation Sterilization
[10884524003634]
Radiation Sterilization
[10884524003634]
Radiation Sterilization
[10884524003634]
Radiation Sterilization
[10884524003634]
Radiation Sterilization
[10884524003634]
Radiation Sterilization
[10884524003634]
Radiation Sterilization
[10884524003634]
Radiation Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-04-23 |
| Device Publish Date | 2016-09-24 |
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 |
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