Primary Device ID | B933ELKIT010 |
NIH Device Record Key | c401103c-c7ad-45d6-b0d1-e8e6bf463755 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | ellacor |
Version Model Number | EL-KIT01 |
Catalog Number | EL-KIT01 |
Company DUNS | 078440636 |
Company Name | Cytrellis Biosystems, 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 | true |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
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 |
Device Issuing Agency | Device ID |
---|---|
HIBCC | B933ELKIT010 [Primary] |
QAI | Powered Microneedle Device |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-01-11 |
Device Publish Date | 2024-01-03 |
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) |
B933ELSYS02 | ellacor System with Micro-Coring Technology includes: Console = EL-CON01 Footswitch = FTS01 Hand |
B933ELKIT02 | Consumables Kit includes the following items: Needle Cartridge, V2 (EL-03N02) Biofilter Suction |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() ELLACOR 88656428 not registered Live/Pending |
Cytrellis Biosystems, Inc. 2019-10-16 |