MiroTract Wound Matrix

GUDID 00857072005484

Wound Matrix

REPRISE BIOMEDICAL, INC.

Collagen wound matrix dressing
Primary Device ID00857072005484
NIH Device Record Key080e699e-9d43-46ec-a1ff-b678d52b8c03
Commercial Distribution StatusIn Commercial Distribution
Brand NameMiroTract Wound Matrix
Version Model Number5030
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

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

Device Dimensions

Length9 Centimeter
Outer Diameter5 Millimeter
Length9 Centimeter
Outer Diameter5 Millimeter
Length9 Centimeter
Outer Diameter5 Millimeter
Length9 Centimeter
Outer Diameter5 Millimeter
Length9 Centimeter
Outer Diameter5 Millimeter
Length9 Centimeter
Outer Diameter5 Millimeter
Length9 Centimeter
Outer Diameter5 Millimeter
Length9 Centimeter
Outer Diameter5 Millimeter
Length9 Centimeter
Outer Diameter5 Millimeter
Length9 Centimeter
Outer Diameter5 Millimeter
Length9 Centimeter
Outer Diameter5 Millimeter
Length9 Centimeter
Outer Diameter5 Millimeter
Length9 Centimeter
Outer Diameter5 Millimeter
Length9 Centimeter
Outer Diameter5 Millimeter
Length9 Centimeter
Outer Diameter5 Millimeter
Length9 Centimeter
Outer Diameter5 Millimeter
Length9 Centimeter
Outer Diameter5 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100857072005484 [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 Date2023-12-29
Device Publish Date2023-12-21

On-Brand Devices [MiroTract Wound Matrix]

00857072005484Wound Matrix
00857072005477Wound Matrix
00857072005460Wound Matrix
00857072005453Wound Matrix

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