Wound CareKit MDXWC033

GUDID 00850050570110

Wound CareKit inclusive of the components needed for a wound dressing change.

Mirodx, LLC

Wound dressing kit, non-medicated
Primary Device ID00850050570110
NIH Device Record Keybe916e0f-07c7-4afe-8a15-52731b05b91c
Commercial Distribution StatusIn Commercial Distribution
Brand NameWound CareKit
Version Model NumberMDXWC03
Catalog NumberMDXWC033
Company DUNS118764449
Company NameMirodx, LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-888-656-3444
Emailhelp@mirodx.com
Phone1-888-656-3444
Emailhelp@mirodx.com
Phone1-888-656-3444
Emailhelp@mirodx.com
Phone1-888-656-3444
Emailhelp@mirodx.com
Phone1-888-656-3444
Emailhelp@mirodx.com
Phone1-888-656-3444
Emailhelp@mirodx.com
Phone1-888-656-3444
Emailhelp@mirodx.com
Phone1-888-656-3444
Emailhelp@mirodx.com
Phone1-888-656-3444
Emailhelp@mirodx.com
Phone1-888-656-3444
Emailhelp@mirodx.com
Phone1-888-656-3444
Emailhelp@mirodx.com
Phone1-888-656-3444
Emailhelp@mirodx.com
Phone1-888-656-3444
Emailhelp@mirodx.com
Phone1-888-656-3444
Emailhelp@mirodx.com
Phone1-888-656-3444
Emailhelp@mirodx.com
Phone1-888-656-3444
Emailhelp@mirodx.com
Phone1-888-656-3444
Emailhelp@mirodx.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100850050570110 [Primary]

FDA Product Code

MCYWound Dressing Kit

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-11-14
Device Publish Date2023-11-06

On-Brand Devices [Wound CareKit ]

00860009502956Wound CareKit inclusive of the components needed for a wound dressing change.
00860009502932Wound CareKit inclusive of the components needed for a wound dressing change.
00860009502925Wound CareKit inclusive of the components needed for a wound dressing change.
00860009502918Wound CareKit inclusive of the components needed for a wound dressing change.
00850050570011Wound CareKit inclusive of the components needed for a wound dressing change.
00860009502970Wound CareKit inclusive of the components needed for a wound dressing change.
00860009502963Wound CareKit inclusive of the components needed for a wound dressing change.
00860009502994Wound CareKit inclusive of the components needed for a dressing change.
00860009502987Wound CareKit inclusive of the components needed for a wound dressing change.
00850050570110Wound CareKit inclusive of the components needed for a wound dressing change.
00850050570103Wound CareKit inclusive of the components needed for a wound dressing change.
00850050570097Wound CareKit inclusive of the components needed for a wound dressing change.

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.