BodyMed Iontophoresis Electrode Kit

GUDID 00853904006063

Compass Richmar, LLC

Drug-delivery iontophoresis patch
Primary Device ID00853904006063
NIH Device Record Key37050ec9-5d08-4a86-8683-3570eb84a22f
Commercial Distribution StatusIn Commercial Distribution
Brand NameBodyMed Iontophoresis Electrode Kit
Version Model NumberLarge (3.5"x3.5")
Company DUNS080930531
Company NameCompass Richmar, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100853904006063 [Primary]

FDA Product Code

EGJDevice, Iontophoresis, Other Uses

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-05-02

On-Brand Devices [BodyMed Iontophoresis Electrode Kit]

00853904006070Butterfly (3.75"x3.75")
00853904006063Large (3.5"x3.5")
00853904006056Medium (3.25"x3.25")
00853904006049Small (2.75"x2.75")
10853904006077Butterfly, Box of 12
10853904006060Large, Box of 12
10853904006053Medium, Box of 12
10853904006046Small, Box of 12

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.