Ellacor EL-03N01
GUDID B933EL03N011
Triple Needle Cartridge (2-Pack)
Cytrellis Biosystems, Inc.
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| NIH Device Record Key | e1d8d0ee-485f-44fe-b391-dc2246874145 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Ellacor |
| Version Model Number | EL-03N01 |
| Catalog Number | EL-03N01 |
| Company DUNS | 078440636 |
| Company Name | Cytrellis Biosystems, Inc. |
| Device Count | 2 |
| 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
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B933EL03N01 [Unit of Use] |
| HIBCC | B933EL03N011 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K202517
FDA Product Code
| QAI | Powered Microneedle Device |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-10-08 |
| Device Publish Date | 2021-09-30 |
On-Brand Devices [Ellacor]
| B933ELHPC010 | Handpiece |
| B933ELFTS010 | Footswitch |
| B933ELCON010 | Console |
| B933ELCCV01 | Cleaning Cover |
| B933EL03N011 | Triple Needle Cartridge (2-Pack) |
| B933EL03N010 | Triple Needle Cartridge |
| B933ELHPC01R0 | Handpiece (Refurbished) |
| B933ELFTS01R0 | Footswitch (Refurbished) |
| B933ELCON01R0 | Console (Refurbished) |
| B933ELSYS01 | ellacor System with Micro-Coring Technology includes: Console = EL-CON02 Handpiece = EL-HPC01 Fo |
| B933ELKIT010 | Consumables Kit includes the following items: Needle Cartridge (EL-03N01) Biofilter Suction Tube |
| B933ELCON02 | ellacor Console 1.1 |
| B933ELCLP011 | Suction tubing clip |
| B933ELHPC02R0 | Handpiece (Refurbished) |
| B933ELHPC02 | Handpiece |
| B933ELCON02R0 | Console (Refurbished) |
Trademark Results [Ellacor]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ELLACOR 88656428 not registered Live/Pending |
Cytrellis Biosystems, Inc. 2019-10-16 |
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