MiroDerm Fenestrated Plus

GUDID 00857072005217

4 x 4 cm Fenestrated Plus Biologic Wound Matrix

REPRISE BIOMEDICAL, INC.

Collagen wound matrix dressing
Primary Device ID00857072005217
NIH Device Record Keyc89612b8-bcbd-4651-8d14-887f8ebedb52
Commercial Distribution StatusIn Commercial Distribution
Brand NameMiroDerm Fenestrated Plus
Version Model NumberBLM-200-03-0404
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100857072005217 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KGNDressing, Wound, Collagen

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-10-08
Device Publish Date2020-09-30

On-Brand Devices [MiroDerm Fenestrated Plus]

008570720052628 x 15 cm Fenestrated Plus Biologic Wound Matrix
008570720052557 x 10 cm Fenestrated Plus Biologic Wound Matrix
008570720052488 x 8 cm Fenestrated Plus Biologic Wound Matrix
008570720052315 x 5 cm Fenestrated Plus Biologic Wound Matrix
008570720052243 x 7 cm Fenestrated Plus Biologic Wound Matrix
008570720052174 x 4 cm Fenestrated Plus Biologic Wound Matrix
008570720052003 x 3 cm Fenestrated Plus Biologic Wound Matrix

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