MiroDerm Fenestrated

GUDID 00857072005125

5 x 5 cm Fenestrated Biologic Wound Matrix

REPRISE BIOMEDICAL, INC.

Collagen wound matrix dressing
Primary Device ID00857072005125
NIH Device Record Keyc71c6fae-919e-43cb-b73a-42bd14dcd338
Commercial Distribution StatusIn Commercial Distribution
Brand NameMiroDerm Fenestrated
Version Model NumberBLM-200-02-0505
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
GS100857072005125 [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]

008570720053092x2 cm Fenestrated Biologic Wound Matrix
008570720052932x3 cm Fenestrated Biologic Wound Matrix
008570720051704 x 4 cm Fenestrated Biologic Wound Matrix
008570720051633 x 3 cm Fenestrated Biologic Wound Matrix
008570720051568 x 15 cm Fenestrated Biologic Wound Matrix
008570720051497 x 10 cm Fenestrated Biologic Wound Matrix
008570720051328 x 8 cm Fenestrated Biologic Wound Matrix
008570720051255 x 5 cm Fenestrated Biologic Wound Matrix
008570720051183 x 7 cm Fenestrated Biologic Wound Matrix

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