MiroFlex®

GUDID 00857072005378

Biologic Matrix

REPRISE BIOMEDICAL, INC.

Extra-gynaecological surgical mesh, collagen, bioabsorbable Extra-gynaecological surgical mesh, collagen, bioabsorbable Extra-gynaecological surgical mesh, collagen, bioabsorbable Extra-gynaecological surgical mesh, collagen, bioabsorbable Extra-gynaecological surgical mesh, collagen, bioabsorbable Extra-gynaecological surgical mesh, collagen, bioabsorbable Extra-gynaecological surgical mesh, collagen, bioabsorbable Extra-gynaecological surgical mesh, collagen, bioabsorbable Extra-gynaecological surgical mesh, collagen, bioabsorbable Extra-gynaecological surgical mesh, collagen, bioabsorbable Extra-gynaecological surgical mesh, collagen, bioabsorbable Extra-gynaecological surgical mesh, collagen, bioabsorbable Extra-gynaecological surgical mesh, collagen, bioabsorbable Extra-gynaecological surgical mesh, collagen, bioabsorbable Extra-gynaecological surgical mesh, collagen, bioabsorbable Extra-gynaecological surgical mesh, collagen, bioabsorbable Extra-gynaecological surgical mesh, collagen, bioabsorbable Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial
Primary Device ID00857072005378
NIH Device Record Keyf77f1d05-8a67-4e5e-89cc-5e4c25998b63
Commercial Distribution StatusIn Commercial Distribution
Brand NameMiroFlex®
Version Model NumberBLM-100-01-1020
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
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

Width10 Centimeter
Height20 Centimeter
Width10 Centimeter
Height20 Centimeter
Width10 Centimeter
Height20 Centimeter
Width10 Centimeter
Height20 Centimeter
Width10 Centimeter
Height20 Centimeter
Width10 Centimeter
Height20 Centimeter
Width10 Centimeter
Height20 Centimeter
Width10 Centimeter
Height20 Centimeter
Width10 Centimeter
Height20 Centimeter
Width10 Centimeter
Height20 Centimeter
Width10 Centimeter
Height20 Centimeter
Width10 Centimeter
Height20 Centimeter
Width10 Centimeter
Height20 Centimeter
Width10 Centimeter
Height20 Centimeter
Width10 Centimeter
Height20 Centimeter
Width10 Centimeter
Height20 Centimeter
Width10 Centimeter
Height20 Centimeter
Width10 Centimeter
Height20 Centimeter
Width10 Centimeter
Height20 Centimeter
Width10 Centimeter
Height20 Centimeter
Width10 Centimeter
Height20 Centimeter
Width10 Centimeter
Height20 Centimeter
Width10 Centimeter
Height20 Centimeter
Width10 Centimeter
Height20 Centimeter
Width10 Centimeter
Height20 Centimeter
Width10 Centimeter
Height20 Centimeter
Width10 Centimeter
Height20 Centimeter
Width10 Centimeter
Height20 Centimeter
Width10 Centimeter
Height20 Centimeter
Width10 Centimeter
Height20 Centimeter
Width10 Centimeter
Height20 Centimeter
Width10 Centimeter
Height20 Centimeter
Width10 Centimeter
Height20 Centimeter
Width10 Centimeter
Height20 Centimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100857072005378 [Primary]

FDA Product Code

FTMMesh, Surgical

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-08-14
Device Publish Date2023-08-04

On-Brand Devices [MiroFlex®]

00857072005408Biologic Matrix
00857072005385Biologic Matrix
00857072005361Biologic Matrix
00857072005354Biologic Matrix
00857072005392Biologic Matrix
00857072005378Biologic Matrix

Trademark Results [MiroFlex]

Mark Image

Registration | Serial
Company
Trademark
Application Date
MIROFLEX
MIROFLEX
90075742 not registered Live/Pending
Reprise Biomedical, Inc.
2020-07-27
MIROFLEX
MIROFLEX
71590627 0560090 Dead/Expired
UNIVERSAL PAINT & VARNISH COMPAY
1950-01-10

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