Megadyne
GUDID 10614559101865
E-Z Clean, PTFE Coated, Electrosurgical Laparoscopic Electrode, Spatula, Single-Use, Tip Only, for use with Reusable Indicator Shaft
MEGADYNE MEDICAL PRODUCTS, INC.
Endoscopic electrosurgical electrode, monopolar, single-use| Primary Device ID | 10614559101865 |
| NIH Device Record Key | 5d6ad8df-407b-4ad9-86e5-7edfe7a54332 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Megadyne |
| Version Model Number | 0618 |
| Company DUNS | 185444825 |
| Company Name | MEGADYNE MEDICAL PRODUCTS, INC. |
| 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
Operating and Storage Conditions
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 50 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10614559101865 [Primary] |
| GS1 | 30614559101869 [Package] Package: BOX [6 Units] In Commercial Distribution |
| GS1 | 50614559101863 [Package] Package: CASE [132 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K943055
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 | 8 |
| Public Version Date | 2021-05-11 |
| Device Publish Date | 2016-12-11 |
On-Brand Devices [Megadyne]
| 10614559105405 | Connector Smoke Evacuator Universal Non-sterile |
| 10614559105399 | Connector 22mm ID Filter to Tubing Non-sterile |
| 10614559105382 | Mega Vac Connector Filter to Tubing Non-sterile |
| 30614559104648 | Megadyne Smoke Evacuator RF Sensor |
| 30614559103009 | Ultra Vac Smoke Evacuation Pencil, Telescopic, Stainless Electrode, 9 Ft (2.74m) Tubing |
| 30614559102996 | Smoke Evacuation Pencil, Telescopic, Stainless Electrode, , 22mm Connector, 9 Ft (2.74m) Tubing |
| 10614559102060 | Connector, Smoke Evacuator to Tubing, 22mm I.D., non-sterile |
| 10614559102053 | Connector Smoke Evacuator Universal Non-sterile |
| 10614559102046 | Connector 22mm ID Filter to Tubing Non-sterile |
| 10614559102039 | Mega Vac Connector Filter to Tubing Non-sterile |
| 30614559104518 | E-Z Clean, Non-stick, PTFE Coated, Electrosurgical Blade Electrode, 4.72 inch (12 cm), Custom |
| 50614559103591 | Electrosurgical Pencil Rocker Switch E-Z Clean Coated Blade Electrode 15 foot (4.6 m) Cord Bulk |
| 50614559103553 | Electrosurgical Pencil Button Switch E-Z Clean Coated Blade Electrode 15 foot (4.6 m) Cord Bulk |
| 10614559103890 | Reusable Patient Return Electrode Cable, Single Plate, 3m (10 ft) |
| 30614559100879 | Patient Return Electrode, Single-Use, non Contact Quality Monitoring, Adult, Without Cord, For P |
| 30614559100855 | Electrosurgical Pencil Button Switch Non Coated Blade Electrode 10 ft (3 m) cord |
| 30614559100831 | Electrosurgical Pencil Rocker Switch Non Coated Blade Electrode 10 ft (3 m) cord |
| 30614559104631 | ZIP Pen Ergonomic Smoke Evacuation Pencil, E-Z Clean, Non-Stick, PTFE Coated, 10 Ft (3.04m) Tub |
| 30614559102934 | Suction Coagulator, Handswitching, 12 Fr, 6 inch (15.24cm) |
| 30614559102927 | Suction Coagulator, Handswitching, 8 Fr, 6 inch (15.24cm) |
| 30614559102910 | Suction Coagulator, Handswitching, 10 Fr, 6 inch (15.24cm) |
| 30614559102903 | Suction Coagulator, Footswitching, 10 Fr, 6 inch (15.24cm) |
| 10614559102886 | Mega Power Cart, unassembled, no top shelf |
| 10614559102879 | Mega Power Cart with Top Shelf |
| 30614559102798 | Suction Coagulator, Footswitching, 10 Fr, 6 inch (15.24cm) |
| 30614559104143 | E-Z Clean, Non-stick, PTFE Coated, Precision Blade Electrode, Modified Insulation, 2.5 in (6.4 c |
| 10614559104507 | Mother Board Subassembly, Motherboard Updated ROHS Faceplate, For Mega Power Generator, R |
| 10614559104170 | Mother Board Subassembly, Motherboard Updated Faceplate, For Mega Power Generator, R |
| 10614559103968 | Mother Board Subassembly, Motherboard Original Faceplate, R |
| 30614559102323 | Stainless Steel, Electrosurgical Laparoscopic Electrode with Indicator, J-Hook, 38 cm., Reusable |
| 30614559102316 | Stainless Steel, Electrosurgical Laparoscopic Electrode with Indicator, J-Hook, 38 cm., Reusable |
| 30614559102309 | Stainless Steel, Electrosurgical Laparoscopic Electrode with Indicator, J-Hook, 32 cm., Reusable |
| 30614559102293 | Stainless Steel, Electrosurgical Laparoscopic Electrode with Indicator, J-Hook, 32 cm., Reusable |
| 30614559102286 | Stainless Steel, Electrosurgical Laparoscopic Electrode with Indicator, L-Hook, Long, 38 cm., Re |
| 30614559102279 | Stainless Steel, Electrosurgical Laparoscopic Electrode with Indicator, L-Hook, Long, 38 cm., Re |
| 30614559102248 | Stainless Steel, Electrosurgical Laparoscopic Electrode with Indicator, Spatula, Long, 38 cm., R |
| 30614559102231 | Stainless Steel, Electrosurgical Laparoscopic Electrode with Indicator, Spatula, Long, 38 cm., R |
| 30614559105966 | Megadyne Telescoping Smoke Evacuation Soft Tissue Dissector, Modified |
| 30614559105959 | Megadyne Telescoping Smoke Evacuation Soft Tissue Dissector |
| 30614559105942 | Megadyne Telescoping Soft Tissue Dissector, Modified |
| 30614559105935 | Megadyne Telescoping Soft Tissue Dissector |
| 30614559105584 | Megadyne Telescoping Smoke Evacuation Pencil - 15 ft tubing with Universal Connector and Holster |
| 30614559105577 | Megadyne Telescoping Smoke Evacuation Pencil - 10 ft tubing with Universal Connector and Holster |
| 10614559104668 | Megadyne Smoke Evacuator Connect Cable, 2.1m |
| 10614559104651 | Megadyne Smoke Evacuator Connect Cable, 1m |
| 10614559104552 | Megadyne MESE1 Smoke Evacuator Filter |
| 10614559104545 | Megadyne Smoke Evacuator |
| 30614559101289 | E-Z Clean, Non-stick, PTFE Coated, Electrosurgical Blade Electrode, 2.5 inch, 6.35 cm, Single-Us |
| 30614559101418 | E-Z Clean, Non-stick, PTFE Coated, Mega Fine Electrosurgical Needle Electrode, Sharp, 2.5 inch ( |
| 30614559100701 | Non Coated Electrosurgical Ball Electrode, 5 inch (12.7cm) |
Trademark Results [Megadyne]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MEGADYNE 79114247 4348527 Live/Registered |
MEGADYNE S.p.A. 2012-04-20 |
 MEGADYNE 76577427 not registered Dead/Abandoned |
Atlantic Ultraviolet Corporation 2004-02-17 |
 MEGADYNE 75934011 not registered Dead/Abandoned |
HANDY CHEMICALS LIMITED 2000-03-03 |
 MEGADYNE 75888500 not registered Dead/Abandoned |
Megadyne Inc. 2000-01-07 |
 MEGADYNE 75277372 2227209 Dead/Cancelled |
MEGADYNE COMPANIES, LLC 1997-04-18 |
 MEGADYNE 75269302 2201076 Live/Registered |
MEGADYNE S.P.A. 1997-04-04 |
 MEGADYNE 75123341 2077389 Live/Registered |
MEGADYNE MEDICAL PRODUCTS, INCORPORATED 1996-06-21 |
 MEGADYNE 74605110 2103781 Dead/Cancelled |
IJAMS, DAVE 1994-12-01 |
 MEGADYNE 73804627 1652977 Live/Registered |
MEGADYNE MEDICAL PRODUCTS, INCORPORATED 1989-06-05 |
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