Primary Device ID | 08051122041039 |
NIH Device Record Key | e79aea0b-a112-42b7-b505-329de5d4d45f |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | UPPER LIMB KIT – 7 WISE |
Version Model Number | SHWM01U7 |
Company DUNS | 429763668 |
Company Name | NCS LAB SRL |
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 | true |
Device Combination Product | false |
Single Use | false |
Lot Batch | true |
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 |
Phone | +39059669813 |
quality@ncs-company.com | |
Phone | +39059669813 |
quality@ncs-company.com | |
Phone | +39059669813 |
quality@ncs-company.com | |
Phone | +39059669813 |
quality@ncs-company.com | |
Phone | +39059669813 |
quality@ncs-company.com | |
Phone | +39059669813 |
quality@ncs-company.com | |
Phone | +39059669813 |
quality@ncs-company.com | |
Phone | +39059669813 |
quality@ncs-company.com | |
Phone | +39059669813 |
quality@ncs-company.com | |
Phone | +39059669813 |
quality@ncs-company.com | |
Phone | +39059669813 |
quality@ncs-company.com | |
Phone | +39059669813 |
quality@ncs-company.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 08051122041039 [Primary] |
ISD | Exerciser, Measuring |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2022-03-22 |
Device Publish Date | 2022-03-14 |
08051122040902 - Shoulder Pacemaker device | 2022-11-29 The configuration is composed of an electrostimulator and other components, useful for recharging, wearing, stimulating and/or c |
08051122040919 - Shoulder Pacemaker device (wireless PC) | 2022-11-29 The configuration is composed of an electrostimulator and other components, useful for recharging, wearing, stimulating and/or c |
08051122040926 - MySPM App | 2022-11-29 Optionally, the electrostimulator (SPM01M1) can require the combined use with the MySPM mobile application, as accessory of the |
08051122040933 - MySPM@Home App | 2022-11-29 Optionally, the electrostimulator (SPM01M1) can require the combined use with the MySPM@Home mobile application, as accessory of |
08051122040940 - Stand-alone mode Kit | 2022-11-29 For the stand-alone mode version of the subject device, the SPM01K1 convenience kit includes: 1 electrostimulator SPM01M1 confi |
08051122040957 - Wireless mode - Kit | 2022-11-29 For the wireless mode version of the subject device, to be used in combination with a dedicated control software running on a pc |
08051122040964 - Wireless app mode - Kit | 2022-11-29 For the wireless mode version of the subject device, to be used in combination with an application installed on a tablet, the SP |
08051122040971 - Wireless app home mode - Kit | 2022-11-29 For the wireless mode version of the subject device, combined with an application installed on a tablet that can be used in a ho |