Miro3D® Fibers

GUDID 00857072005446

Wound matrix

REPRISE BIOMEDICAL, INC.

Collagen wound matrix dressing
Primary Device ID00857072005446
NIH Device Record Key3126ced8-ae0e-4f93-94b2-91c8b28d0550
Commercial Distribution StatusIn Commercial Distribution
Brand NameMiro3D® Fibers
Version Model Number4015
Company DUNS043611421
Company NameREPRISE BIOMEDICAL, INC.
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 Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone952-377-8238
Emailcustomerservice@reprisebio.com
Phone952-377-8238
Emailcustomerservice@reprisebio.com
Phone952-377-8238
Emailcustomerservice@reprisebio.com
Phone952-377-8238
Emailcustomerservice@reprisebio.com
Phone952-377-8238
Emailcustomerservice@reprisebio.com
Phone952-377-8238
Emailcustomerservice@reprisebio.com
Phone952-377-8238
Emailcustomerservice@reprisebio.com
Phone952-377-8238
Emailcustomerservice@reprisebio.com
Phone952-377-8238
Emailcustomerservice@reprisebio.com
Phone952-377-8238
Emailcustomerservice@reprisebio.com
Phone952-377-8238
Emailcustomerservice@reprisebio.com
Phone952-377-8238
Emailcustomerservice@reprisebio.com
Phone952-377-8238
Emailcustomerservice@reprisebio.com
Phone952-377-8238
Emailcustomerservice@reprisebio.com
Phone952-377-8238
Emailcustomerservice@reprisebio.com
Phone952-377-8238
Emailcustomerservice@reprisebio.com
Phone952-377-8238
Emailcustomerservice@reprisebio.com
Phone952-377-8238
Emailcustomerservice@reprisebio.com
Phone952-377-8238
Emailcustomerservice@reprisebio.com
Phone952-377-8238
Emailcustomerservice@reprisebio.com
Phone952-377-8238
Emailcustomerservice@reprisebio.com
Phone952-377-8238
Emailcustomerservice@reprisebio.com
Phone952-377-8238
Emailcustomerservice@reprisebio.com
Phone952-377-8238
Emailcustomerservice@reprisebio.com
Phone952-377-8238
Emailcustomerservice@reprisebio.com
Phone952-377-8238
Emailcustomerservice@reprisebio.com
Phone952-377-8238
Emailcustomerservice@reprisebio.com
Phone952-377-8238
Emailcustomerservice@reprisebio.com
Phone952-377-8238
Emailcustomerservice@reprisebio.com
Phone952-377-8238
Emailcustomerservice@reprisebio.com

Device Dimensions

Weight700 Milligram
Weight700 Milligram
Weight700 Milligram
Weight700 Milligram
Weight700 Milligram
Weight700 Milligram
Weight700 Milligram
Weight700 Milligram
Weight700 Milligram
Weight700 Milligram
Weight700 Milligram
Weight700 Milligram
Weight700 Milligram
Weight700 Milligram
Weight700 Milligram
Weight700 Milligram
Weight700 Milligram
Weight700 Milligram
Weight700 Milligram
Weight700 Milligram
Weight700 Milligram
Weight700 Milligram
Weight700 Milligram
Weight700 Milligram
Weight700 Milligram
Weight700 Milligram
Weight700 Milligram
Weight700 Milligram
Weight700 Milligram
Weight700 Milligram

Device Identifiers

Device Issuing AgencyDevice ID
GS100857072005446 [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 Date2022-12-01
Device Publish Date2022-11-23

On-Brand Devices [Miro3D® Fibers]

00857072005446Wound matrix
00857072005439Wound matrix
00857072005422Wound matrix
00857072005415Wound matrix

Trademark Results [Miro3D]

Mark Image

Registration | Serial
Company
Trademark
Application Date
MIRO3D
MIRO3D
90075721 not registered Live/Pending
Reprise Biomedical, Inc.
2020-07-27

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