MACROLYTE 425-2801
GUDID 20653405007262
MACROLYTE PEDIATRIC DUAL DISPERSIVE ELECTRODE
Conmed Corporation
Circulating immune complex (CIC) IVD, reagent Circulating immune complex (CIC) IVD, reagent Electrosurgical return electrode, single-use Electrosurgical return electrode, single-use Electrosurgical return electrode, single-use Electrosurgical return electrode, single-use Electrosurgical return electrode, single-use Electrosurgical return electrode, single-use Electrosurgical return electrode, single-use Electrosurgical return electrode, single-use Electrosurgical return electrode, single-use Electrosurgical return electrode, single-use Electrosurgical return electrode, single-use Electrosurgical return electrode, single-use Electrosurgical return electrode, single-use Electrosurgical return electrode, single-use Electrosurgical return electrode, single-use Electrosurgical return electrode, single-use Electrosurgical return electrode, single-use| Primary Device ID | 20653405007262 |
| NIH Device Record Key | a7201233-b17c-486d-9c2b-9fb03d8624df |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MACROLYTE |
| Version Model Number | 425-2801 |
| Catalog Number | 425-2801 |
| Company DUNS | 071595540 |
| Company Name | Conmed Corporation |
| Device Count | 100 |
| 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(800)237-0169 |
| CUSTOMER_SERVICE@CONMED.COM | |
| Phone | +1(800)237-0169 |
| CUSTOMER_SERVICE@CONMED.COM | |
| Phone | +1(800)237-0169 |
| CUSTOMER_SERVICE@CONMED.COM | |
| Phone | +1(800)237-0169 |
| CUSTOMER_SERVICE@CONMED.COM | |
| Phone | +1(800)237-0169 |
| CUSTOMER_SERVICE@CONMED.COM | |
| Phone | +1(800)237-0169 |
| CUSTOMER_SERVICE@CONMED.COM | |
| Phone | +1(800)237-0169 |
| CUSTOMER_SERVICE@CONMED.COM | |
| Phone | +1(800)237-0169 |
| CUSTOMER_SERVICE@CONMED.COM | |
| Phone | +1(800)237-0169 |
| CUSTOMER_SERVICE@CONMED.COM | |
| Phone | +1(800)237-0169 |
| CUSTOMER_SERVICE@CONMED.COM | |
| Phone | +1(800)237-0169 |
| CUSTOMER_SERVICE@CONMED.COM | |
| Phone | +1(800)237-0169 |
| CUSTOMER_SERVICE@CONMED.COM | |
| Phone | +1(800)237-0169 |
| CUSTOMER_SERVICE@CONMED.COM | |
| Phone | +1(800)237-0169 |
| CUSTOMER_SERVICE@CONMED.COM | |
| Phone | +1(800)237-0169 |
| CUSTOMER_SERVICE@CONMED.COM | |
| Phone | +1(800)237-0169 |
| CUSTOMER_SERVICE@CONMED.COM | |
| Phone | +1(800)237-0169 |
| CUSTOMER_SERVICE@CONMED.COM | |
| Phone | +1(800)237-0169 |
| CUSTOMER_SERVICE@CONMED.COM | |
| Phone | +1(800)237-0169 |
| CUSTOMER_SERVICE@CONMED.COM |
Operating and Storage Conditions
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between 16 Degrees Celsius and 27 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between 16 Degrees Celsius and 27 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Handling Environment Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Handling Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between 16 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Handling Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between 16 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Handling Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between 16 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Handling Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between 16 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Handling Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between 16 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Handling Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between 16 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Handling Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between 16 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Handling Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between 16 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Handling Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between 16 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Handling Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between 16 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Handling Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between 16 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Handling Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between 16 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Handling Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between 16 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Handling Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between 16 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Handling Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between 16 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Handling Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between 16 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Handling Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between 16 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00653405007268 [Unit of Use] |
| GS1 | 20653405007262 [Package] Contains: 30653405007269 Package: BOX [100 Units] In Commercial Distribution |
| GS1 | 30653405007269 [Primary] |
FDA Product Code
| GEI | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-09-24 |
On-Brand Devices [MACROLYTE]
| 20653405007330 | MACROLYTE INFANT DISPERSIVE ELECTRODE |
| 20653405007293 | MACROLYTE PREMIE DISPERSIVE ELECTRODE |
| 20653405007262 | MACROLYTE PEDIATRIC DUAL DISPERSIVE ELECTRODE |
| 20653405007224 | MACROLYTE PEDIATRIC DISPERSIVE ELECTRODE |
| 20653405007187 | MACROLYTE PEDIATRIC DUAL DISPERSIVE ELECTRODE |
| 20653405007019 | MACROLYTE DISPERSIVE ELECTRODE |
| 20653405006999 | MACROLYTE DISPERSIVE ELECTRODE |
| 00653405987614 | GROUND PAD:AD;SGN FOIL, COOPER |
Trademark Results [MACROLYTE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MACROLYTE 73562513 1390441 Live/Registered |
CONSOLIDATED MEDICAL EQUIPMENT, INC. 1985-10-10 |
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