ZIP Pen
GUDID 30614559105324
Zip Pen Extension Nozzle 2.7" (6.8 cm)
MEGADYNE MEDICAL PRODUCTS, INC.
Surgical plume evacuation system Surgical plume evacuation system Surgical plume evacuation system Surgical plume evacuation system Surgical plume evacuation system Surgical plume evacuation system Surgical plume evacuation system Surgical plume evacuation system Surgical plume evacuation system Surgical plume evacuation system Surgical plume evacuation system Surgical plume evacuation system Surgical plume evacuation system Surgical plume evacuation system Surgical plume evacuation system Surgical plume evacuation system Surgical plume evacuation system Surgical plume evacuation system Surgical plume evacuation system Surgical plume evacuation system Surgical plume evacuation system Surgical plume evacuation system Surgical plume evacuation system Surgical plume evacuation system Surgical plume evacuation system Surgical plume evacuation system Surgical plume evacuation system| Primary Device ID | 30614559105324 |
| NIH Device Record Key | 868c9ff1-9842-47df-b9b1-b74d0df7e57e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ZIP Pen |
| Version Model Number | 2540J |
| Company DUNS | 185444825 |
| Company Name | MEGADYNE MEDICAL PRODUCTS, INC. |
| Device Count | 1 |
| DM Exempt | true |
| 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10614559105320 [Primary] |
| GS1 | 30614559105324 [Package] Contains: 10614559105320 Package: [10 Units] In Commercial Distribution |
| GS1 | 50614559105328 [Package] Package: [10 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K141587
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 | 3 |
| Public Version Date | 2020-12-16 |
| Device Publish Date | 2018-09-04 |
On-Brand Devices [ZIP Pen]
| 30614559104327 | ZIP Pen Ergonomic Smoke Evacuation Pencil E-Z Clean, Non-Stick, PTFE Coated, 10 Ft (3.04m) Tubin |
| 30614559104044 | ZIP Pen Ergonomic Smoke Evacuation Pencil, E-Z Clean, Non-Stick, PTFE Coated, 10 Ft (3.04m) Tub |
| 30614559105751 | Zip Pen Extension Nozzle 5.2" (13.2 cm) |
| 30614559105348 | ZIP Pen Ergonomic Smoke Evacuation Pencil E-Z Clean, Non-Stick, PTFE Coated, 10 Ft (3.04m) Tubin |
| 30614559105324 | Zip Pen Extension Nozzle 2.7" (6.8 cm) |
| 10614559105757 | Zip Pen Extension Nozzle 5.2" (13.2 cm) |
| 10614559105344 | ZIP Pen Ergonomic Smoke Evacuation Pencil E-Z Clean, Non-Stick, PTFE Coated, 10 Ft (3.04m) Tubin |
| 10614559105337 | ZIP Pen Ergonomic Smoke Evacuation Pencil, E-Z Clean, Non-Stick, PTFE Coated, 10 Ft (3.04m) Tub |
| 10614559105320 | Zip Pen Extension Nozzle 2.7" (6.8 cm) |
| 30614559104198 | Zip Pen Extension Nozzle 5.2" (13.2 cm) |
| 30614559104181 | Zip Pen Extension Nozzle 2.7" (6.8 cm) |
Trademark Results [ZIP Pen]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ZIP PEN 78308210 2927042 Dead/Cancelled |
Coolpen LLC 2003-10-01 |
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