Proformix PR-0205

GUDID M070PR02051

Multi-purpose Implantable surgical mesh, collagen, bioabsorable- for use in procedure such as achilles repair, rotator cuff and ligments.

STELLEN MEDICAL, LLC

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 IDM070PR02051
NIH Device Record Keya031152b-cdc9-4d2f-b925-abd982a7d7b3
Commercial Distribution StatusIn Commercial Distribution
Brand NameProformix
Version Model NumberPR-0205
Catalog NumberPR-0205
Company DUNS801160037
Company NameSTELLEN MEDICAL, LLC
Device Count1
DM Exempttrue
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone651-426-1496
Emailcustomerservice@stellenmedical.com
Phone651-426-1496
Emailcustomerservice@stellenmedical.com
Phone651-426-1496
Emailcustomerservice@stellenmedical.com
Phone651-426-1496
Emailcustomerservice@stellenmedical.com
Phone651-426-1496
Emailcustomerservice@stellenmedical.com
Phone651-426-1496
Emailcustomerservice@stellenmedical.com
Phone651-426-1496
Emailcustomerservice@stellenmedical.com
Phone651-426-1496
Emailcustomerservice@stellenmedical.com
Phone651-426-1496
Emailcustomerservice@stellenmedical.com
Phone651-426-1496
Emailcustomerservice@stellenmedical.com
Phone651-426-1496
Emailcustomerservice@stellenmedical.com
Phone651-426-1496
Emailcustomerservice@stellenmedical.com
Phone651-426-1496
Emailcustomerservice@stellenmedical.com
Phone651-426-1496
Emailcustomerservice@stellenmedical.com
Phone651-426-1496
Emailcustomerservice@stellenmedical.com
Phone651-426-1496
Emailcustomerservice@stellenmedical.com
Phone651-426-1496
Emailcustomerservice@stellenmedical.com
Phone651-426-1496
Emailcustomerservice@stellenmedical.com
Phone651-426-1496
Emailcustomerservice@stellenmedical.com
Phone651-426-1496
Emailcustomerservice@stellenmedical.com
Phone651-426-1496
Emailcustomerservice@stellenmedical.com
Phone651-426-1496
Emailcustomerservice@stellenmedical.com
Phone651-426-1496
Emailcustomerservice@stellenmedical.com

Device Dimensions

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Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM070PR02051 [Primary]

FDA Product Code

FTMMesh, Surgical

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2022-06-10
Device Publish Date2015-04-01

On-Brand Devices [Proformix]

M070PR05101Multi-purpose implantable surgical mesh, collagen, bioabsorbable-for use in procedures such as a
M070PR04071Multi-purpose implantable surgical mesh, collagen, bioabsorbable-for use in procedures such as a
M070PR02051Multi-purpose Implantable surgical mesh, collagen, bioabsorable- for use in procedure such as ac

Trademark Results [Proformix]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PROFORMIX
PROFORMIX
85352733 4400621 Live/Registered
STELLEN MEDICAL, LLC
2011-06-22
PROFORMIX
PROFORMIX
78110135 2811708 Dead/Cancelled
CHEVRON INTELLECTUAL PROPERTY LLC
2002-02-21
PROFORMIX
PROFORMIX
78092323 not registered Dead/Abandoned
ChevronTexaco Corporation
2001-11-08
PROFORMIX
PROFORMIX
75626029 not registered Dead/Abandoned
PROFORMIX LTD.
1999-01-25
PROFORMIX
PROFORMIX
75047612 2030100 Dead/Cancelled
1320235 ONTARIO INC.
1996-01-24

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