MiroDry™

GUDID 00857072005521

Wound Matrix

REPRISE BIOMEDICAL, INC.

Collagen wound matrix dressing
Primary Device ID00857072005521
NIH Device Record Key98074201-51a2-43df-86e8-3071fc04c7ac
Commercial Distribution StatusIn Commercial Distribution
Brand NameMiroDry™
Version Model Number6015
Company DUNS043611421
Company NameREPRISE BIOMEDICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Length5 Centimeter
Width5 Centimeter
Length5 Centimeter
Width5 Centimeter
Length5 Centimeter
Width5 Centimeter
Length5 Centimeter
Width5 Centimeter
Length5 Centimeter
Width5 Centimeter
Length5 Centimeter
Width5 Centimeter
Length5 Centimeter
Width5 Centimeter
Length5 Centimeter
Width5 Centimeter
Length5 Centimeter
Width5 Centimeter
Length5 Centimeter
Width5 Centimeter
Length5 Centimeter
Width5 Centimeter
Length5 Centimeter
Width5 Centimeter
Length5 Centimeter
Width5 Centimeter
Length5 Centimeter
Width5 Centimeter
Length5 Centimeter
Width5 Centimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100857072005521 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KGNWound Dressing With Animal-Derived Material(S)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-04-05
Device Publish Date2024-03-28

On-Brand Devices [MiroDry™ ]

00857072005545Wound Matrix
00857072005538Wound Matrix
00857072005521Wound Matrix
00857072005514Wound Matrix
00857072005507Wound Matrix
00857072005491Wound Matrix

Trademark Results [MiroDry]

Mark Image

Registration | Serial
Company
Trademark
Application Date
MIRODRY
MIRODRY
98323666 not registered Live/Pending
Reprise Biomedical, Inc.
2023-12-20

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