Primary Device ID | B493SW0043 |
NIH Device Record Key | 825ebf52-4ce5-4758-975a-f04350e9cc41 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Kintinuum™ |
Version Model Number | SW-0043 |
Company DUNS | 829221139 |
Company Name | MC10, INC. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
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 | false |
Manufacturing Date | false |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | true |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | 8572145630 |
support@mc10inc.com | |
Phone | 8572145630 |
support@mc10inc.com | |
Phone | 8572145630 |
support@mc10inc.com | |
Phone | 8572145630 |
support@mc10inc.com | |
Phone | 8572145630 |
support@mc10inc.com | |
Phone | 8572145630 |
support@mc10inc.com | |
Phone | 8572145630 |
support@mc10inc.com | |
Phone | 8572145630 |
support@mc10inc.com | |
Phone | 8572145630 |
support@mc10inc.com | |
Phone | 8572145630 |
support@mc10inc.com | |
Phone | 8572145630 |
support@mc10inc.com | |
Phone | 8572145630 |
support@mc10inc.com | |
Phone | 8572145630 |
support@mc10inc.com | |
Phone | 8572145630 |
support@mc10inc.com | |
Phone | 8572145630 |
support@mc10inc.com | |
Phone | 8572145630 |
support@mc10inc.com | |
Phone | 8572145630 |
support@mc10inc.com | |
Phone | 8572145630 |
support@mc10inc.com | |
Phone | 8572145630 |
support@mc10inc.com | |
Phone | 8572145630 |
support@mc10inc.com | |
Phone | 8572145630 |
support@mc10inc.com | |
Phone | 8572145630 |
support@mc10inc.com | |
Phone | 8572145630 |
support@mc10inc.com | |
Phone | 8572145630 |
support@mc10inc.com | |
Phone | 8572145630 |
support@mc10inc.com | |
Phone | 8572145630 |
support@mc10inc.com | |
Phone | 8572145630 |
support@mc10inc.com | |
Phone | 8572145630 |
support@mc10inc.com | |
Phone | 8572145630 |
support@mc10inc.com | |
Phone | 8572145630 |
support@mc10inc.com | |
Phone | 8572145630 |
support@mc10inc.com | |
Phone | 8572145630 |
support@mc10inc.com | |
Phone | 8572145630 |
support@mc10inc.com | |
Phone | 8572145630 |
support@mc10inc.com | |
Phone | 8572145630 |
support@mc10inc.com |
Device Issuing Agency | Device ID |
---|---|
HIBCC | B493SW0043 [Primary] |
ISD | Exerciser, Measuring |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2020-03-05 |
Device Publish Date | 2019-02-01 |
B493SW0043 | Web application |
B493SW0042 | Patient application for Android |
B493MC0016 | Instructions for use |
B493MC0011 | MC-0011 kit containing DIs B493BRCS02, B493BRCD02, B493BRCP03, B493BSPS01, B493BRCA05, B493MC000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
KINTINUUM 87828840 not registered Live/Pending |
MC10, Inc. 2018-03-10 |