Bela MD+

GUDID 00754016214042

Luvo Medical Technologies Inc

Analgesic transcutaneous electrical nerve stimulation system
Primary Device ID00754016214042
NIH Device Record Keya5a6420e-ac27-4e4c-a72e-966e011e822b
Commercial Distribution StatusIn Commercial Distribution
Brand NameBela MD+
Version Model NumberESK-2281HD
Company DUNS204046564
Company NameLuvo Medical Technologies Inc
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100754016214042 [Primary]

FDA Product Code

GFEBrush, Dermabrasion, Powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-06-09
Device Publish Date2021-06-01

Devices Manufactured by Luvo Medical Technologies Inc

00754016214134 - Darwin 2022-10-24
00754016214158 - Darwin IPL Handpiece2022-10-24
00754016214165 - Darwin Diode Laser Handpiece2022-10-24
00754016214172 - RF Microneedling Handpiece2022-10-24
00754016214189 - Darwin RF Thermal2022-10-24
00754016214127 - World PRP2021-08-19
00754016214028 - Bare 8082021-06-10
00754016214035 - BARE: 808 HANDPIECE 2021-06-10

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