Endoform Surface

GUDID 09421904065673

Endoform Surface is intended for applications in plastic and reconstructive surgery or to cover, protect, and provide a moist wound environment. The device may be fixed, via sutures, staples, or tacks to the surrounding tissue, if desired.

AROA BIOSURGERY LIMITED

Multi-purpose 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 ID09421904065673
NIH Device Record Key2cb8581a-7572-447a-b742-1fbdbd57b32a
Commercial Distribution Discontinuation2019-03-31
Commercial Distribution StatusNot in Commercial Distribution
Brand NameEndoform Surface
Version Model NumberSR03LG1020
Company DUNS594540572
Company NameAROA BIOSURGERY LIMITED
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

Phone860-337-7730
Emailcustomerservice@appulsemed.com
Phone860-337-7730
Emailcustomerservice@appulsemed.com
Phone860-337-7730
Emailcustomerservice@appulsemed.com
Phone860-337-7730
Emailcustomerservice@appulsemed.com
Phone860-337-7730
Emailcustomerservice@appulsemed.com
Phone860-337-7730
Emailcustomerservice@appulsemed.com
Phone860-337-7730
Emailcustomerservice@appulsemed.com
Phone860-337-7730
Emailcustomerservice@appulsemed.com
Phone860-337-7730
Emailcustomerservice@appulsemed.com
Phone860-337-7730
Emailcustomerservice@appulsemed.com
Phone860-337-7730
Emailcustomerservice@appulsemed.com
Phone860-337-7730
Emailcustomerservice@appulsemed.com
Phone860-337-7730
Emailcustomerservice@appulsemed.com
Phone860-337-7730
Emailcustomerservice@appulsemed.com
Phone860-337-7730
Emailcustomerservice@appulsemed.com
Phone860-337-7730
Emailcustomerservice@appulsemed.com
Phone860-337-7730
Emailcustomerservice@appulsemed.com
Phone860-337-7730
Emailcustomerservice@appulsemed.com
Phone860-337-7730
Emailcustomerservice@appulsemed.com
Phone860-337-7730
Emailcustomerservice@appulsemed.com
Phone860-337-7730
Emailcustomerservice@appulsemed.com
Phone860-337-7730
Emailcustomerservice@appulsemed.com
Phone860-337-7730
Emailcustomerservice@appulsemed.com
Phone860-337-7730
Emailcustomerservice@appulsemed.com

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Operating and Storage Conditions

Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 104 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS109421904065673 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FTMMesh, Surgical

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2020-05-06
Device Publish Date2018-07-02

On-Brand Devices [Endoform Surface]

09421904065697Endoform Surface is intended for applications in plastic and reconstructive surgery or to cover,
09421904065680Endoform Surface is intended for applications in plastic and reconstructive surgery or to cover,
09421904065673Endoform Surface is intended for applications in plastic and reconstructive surgery or to cover,
09421904065666Endoform Surface is intended for applications in plastic and reconstructive surgery or to cover,

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