PlasmaMD CS-100001
GUDID 08600103856010
Electrosurgical Handpiece
Med Pen Concepts LLC
Electrosurgical handpiece, reusable| Primary Device ID | 08600103856010 |
| NIH Device Record Key | 2d611bbf-0eb3-4ae2-8648-32890a68126b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PlasmaMD |
| Version Model Number | PlasmaMD |
| Catalog Number | CS-100001 |
| Company DUNS | 119006347 |
| Company Name | Med Pen Concepts LLC |
| 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 | false |
| Lot Batch | false |
| Serial Number | true |
| 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 | (800) 274-5684 |
| support@plasmaconcepts.com | |
| Phone | (800) 274-5684 |
| support@plasmaconcepts.com | |
| Phone | (800) 274-5684 |
| support@plasmaconcepts.com | |
| Phone | (800) 274-5684 |
| support@plasmaconcepts.com | |
| Phone | (800) 274-5684 |
| support@plasmaconcepts.com | |
| Phone | (800) 274-5684 |
| support@plasmaconcepts.com | |
| Phone | (800) 274-5684 |
| support@plasmaconcepts.com | |
| Phone | (800) 274-5684 |
| support@plasmaconcepts.com | |
| Phone | (800) 274-5684 |
| support@plasmaconcepts.com | |
| Phone | (800) 274-5684 |
| support@plasmaconcepts.com | |
| Phone | (800) 274-5684 |
| support@plasmaconcepts.com | |
| Phone | (800) 274-5684 |
| support@plasmaconcepts.com | |
| Phone | (800) 274-5684 |
| support@plasmaconcepts.com | |
| Phone | (800) 274-5684 |
| support@plasmaconcepts.com | |
| Phone | (800) 274-5684 |
| support@plasmaconcepts.com | |
| Phone | (800) 274-5684 |
| support@plasmaconcepts.com | |
| Phone | (800) 274-5684 |
| support@plasmaconcepts.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08600103856010 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K223440
FDA Product Code
| QVJ | Low Power Electrosurgical Devices For Skin Lesion Destruction |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-08-24 |
| Device Publish Date | 2023-07-20 |
Devices Manufactured by Med Pen Concepts LLC
| 08600103856010 - PlasmaMD | 2023-08-24Electrosurgical Handpiece |
| 08600103856010 - PlasmaMD | 2023-08-24 Electrosurgical Handpiece |
| 08600103856027 - Plasma+ | 2023-08-23 Electrosurgical Handpiece |
| 08600103856034 - Plasma Concepts Professional Plasma Tip Treatment Pack | 2023-08-23 Electrode Tip - Professional Plasma Tip Treatment Pack (Single) |
Trademark Results [PlasmaMD]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PLASMAMD 90054771 not registered Live/Pending |
Aesthetics Biomedical, Inc. 2020-07-15 |
 PLASMAMD 90054750 not registered Live/Pending |
Aesthetics Biomedical, Inc. 2020-07-15 |
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