SurgiMend®

GUDID 10381780357353

SurgiMend® MP Collagen Matrix for Soft Tissue Reconstruction

TEI BIOSCIENCES INC.

Extra-gynaecological surgical mesh, collagen, non-bioabsorbable Extra-gynaecological surgical mesh, collagen, non-bioabsorbable Extra-gynaecological surgical mesh, collagen, non-bioabsorbable Extra-gynaecological surgical mesh, collagen, non-bioabsorbable Extra-gynaecological surgical mesh, collagen, non-bioabsorbable Extra-gynaecological surgical mesh, collagen, non-bioabsorbable Extra-gynaecological surgical mesh, collagen, non-bioabsorbable Extra-gynaecological surgical mesh, collagen, non-bioabsorbable Extra-gynaecological surgical mesh, collagen, non-bioabsorbable Extra-gynaecological surgical mesh, collagen, non-bioabsorbable Extra-gynaecological surgical mesh, collagen, non-bioabsorbable Extra-gynaecological surgical mesh, collagen, non-bioabsorbable Extra-gynaecological surgical mesh, collagen, non-bioabsorbable Extra-gynaecological surgical mesh, collagen, non-bioabsorbable Extra-gynaecological surgical mesh, collagen, non-bioabsorbable Extra-gynaecological surgical mesh, collagen, non-bioabsorbable Extra-gynaecological surgical mesh, collagen, non-bioabsorbable Extra-gynaecological surgical mesh, collagen, non-bioabsorbable Extra-gynaecological surgical mesh, collagen, non-bioabsorbable Extra-gynaecological surgical mesh, collagen, non-bioabsorbable Extra-gynaecological surgical mesh, collagen, non-bioabsorbable Extra-gynaecological surgical mesh, collagen, non-bioabsorbable Extra-gynaecological surgical mesh, collagen, non-bioabsorbable Extra-gynaecological surgical mesh, collagen, non-bioabsorbable Extra-gynaecological surgical mesh, collagen, non-bioabsorbable Extra-gynaecological surgical mesh, collagen, non-bioabsorbable Extra-gynaecological surgical mesh, collagen, non-bioabsorbable Extra-gynaecological surgical mesh, collagen, non-bioabsorbable Extra-gynaecological surgical mesh, collagen, non-bioabsorbable Extra-gynaecological surgical mesh, collagen, non-bioabsorbable Extra-gynaecological surgical mesh, collagen, non-bioabsorbable Extra-gynaecological surgical mesh, collagen, non-bioabsorbable Extra-gynaecological surgical mesh, collagen, non-bioabsorbable Extra-gynaecological surgical mesh, collagen, non-bioabsorbable Extra-gynaecological surgical mesh, collagen, non-bioabsorbable Extra-gynaecological surgical mesh, collagen, non-bioabsorbable Extra-gynaecological surgical mesh, collagen, non-bioabsorbable Extra-gynaecological surgical mesh, collagen, non-bioabsorbable
Primary Device ID10381780357353
NIH Device Record Key3d3f44d3-da85-471d-a1cc-31eec6c6bf16
Commercial Distribution StatusIn Commercial Distribution
Brand NameSurgiMend®
Version Model Number606-206-004
Company DUNS796253292
Company NameTEI BIOSCIENCES 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 Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com

Device Dimensions

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Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from excessive heat and direct sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from excessive heat and direct sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from excessive heat and direct sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from excessive heat and direct sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from excessive heat and direct sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from excessive heat and direct sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from excessive heat and direct sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from excessive heat and direct sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from excessive heat and direct sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from excessive heat and direct sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from excessive heat and direct sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from excessive heat and direct sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from excessive heat and direct sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from excessive heat and direct sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from excessive heat and direct sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from excessive heat and direct sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from excessive heat and direct sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from excessive heat and direct sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from excessive heat and direct sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from excessive heat and direct sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from excessive heat and direct sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from excessive heat and direct sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from excessive heat and direct sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from excessive heat and direct sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from excessive heat and direct sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from excessive heat and direct sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from excessive heat and direct sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from excessive heat and direct sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from excessive heat and direct sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from excessive heat and direct sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from excessive heat and direct sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from excessive heat and direct sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from excessive heat and direct sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from excessive heat and direct sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from excessive heat and direct sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from excessive heat and direct sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from excessive heat and direct sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from excessive heat and direct sunlight.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS110381780357353 [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 Number5
Public Version Date2022-06-10
Device Publish Date2017-05-26

On-Brand Devices [SurgiMend®]

10381780113287SurgiMend is an acellular dermal tissue matrix derived from bovine dermis. The device is suppl
10381780113270SurgiMend is an acellular dermal tissue matrix derived from bovine dermis. The device is suppl
10381780113263SurgiMend is an acellular dermal tissue matrix derived from bovine dermis. The device is suppl
10381780113256SurgiMend is an acellular dermal tissue matrix derived from bovine dermis. The device is suppl
10381780113249SurgiMend is an acellular dermal tissue matrix derived from bovine dermis. The device is suppl
10381780113232SurgiMend is an acellular dermal tissue matrix derived from bovine dermis. The device is suppl
10381780113225SurgiMend is an acellular dermal tissue matrix derived from bovine dermis. The device is suppl
10381780113218SurgiMend is an acellular dermal tissue matrix derived from bovine dermis. The device is suppl
10381780113201SurgiMend is an acellular dermal tissue matrix derived from bovine dermis. The device is suppl
10381780113195SurgiMend is an acellular dermal tissue matrix derived from bovine dermis. The device is suppl
10381780113188SurgiMend is an acellular dermal tissue matrix derived from bovine dermis. The device is suppl
10381780113171SurgiMend is an acellular dermal tissue matrix derived from bovine dermis. The device is suppl
10381780113164SurgiMend is an acellular dermal tissue matrix derived from bovine dermis. The device is suppl
10381780113157SurgiMend is an acellular dermal tissue matrix derived from bovine dermis. The device is suppl
10381780113140SurgiMend is an acellular dermal tissue matrix derived from bovine dermis. The device is suppl
10381780113133SurgiMend is an acellular dermal tissue matrix derived from bovine dermis. The device is suppl
10381780113126SurgiMend is an acellular dermal tissue matrix derived from bovine dermis. The device is suppl
10381780113119SurgiMend is an acellular dermal tissue matrix derived from bovine dermis. The device is suppl
10381780113102SurgiMend is an acellular dermal tissue matrix derived from bovine dermis. The device is suppl
10381780113096SurgiMend is an acellular dermal tissue matrix derived from bovine dermis. The device is suppl
10381780113089SurgiMend is an acellular dermal tissue matrix derived from bovine dermis. The device is suppl
10381780113072SurgiMend is an acellular dermal tissue matrix derived from bovine dermis. The device is suppl
10381780113065SurgiMend is an acellular dermal tissue matrix derived from bovine dermis. The device is suppl
10381780113041SurgiMend is an acellular dermal tissue matrix derived from bovine dermis. The device is suppl
10381780113034SurgiMend is an acellular dermal tissue matrix derived from bovine dermis. The device is suppl
10381780113010SurgiMend is an acellular dermal tissue matrix derived from bovine dermis. The device is suppl
10381780113003SurgiMend is an acellular dermal tissue matrix derived from bovine dermis. The device is suppl
10381780112990SurgiMend is an acellular dermal tissue matrix derived from bovine dermis. The device is suppl
10381780112983SurgiMend is an acellular dermal tissue matrix derived from bovine dermis. The device is suppl
10381780112976SurgiMend is an acellular dermal tissue matrix derived from bovine dermis. The device is suppl
10381780112952SurgiMend is an acellular dermal tissue matrix derived from bovine dermis. The device is suppl
10381780112921SurgiMend is an acellular dermal tissue matrix derived from bovine dermis. The device is suppl
10381780112914SurgiMend is an acellular dermal tissue matrix derived from bovine dermis. The device is suppl
10381780112891SurgiMend is an acellular dermal tissue matrix derived from bovine dermis. The device is suppl
10381780112884SurgiMend is an acellular dermal tissue matrix derived from bovine dermis. The device is suppl
10381780112877SurgiMend is an acellular dermal tissue matrix derived from bovine dermis. The device is suppl
10381780112860SurgiMend is an acellular dermal tissue matrix derived from bovine dermis. The device is suppl
10381780112853SurgiMend is an acellular dermal tissue matrix derived from bovine dermis. The device is suppl
10381780112846SurgiMend is an acellular dermal tissue matrix derived from bovine dermis. The device is suppl
10381780112839SurgiMend is an acellular dermal tissue matrix derived from bovine dermis. The device is suppl
10381780112822SurgiMend is an acellular dermal tissue matrix derived from bovine dermis. The device is suppl
10381780112815SurgiMend is an acellular dermal tissue matrix derived from bovine dermis. The device is suppl
10381780112808SurgiMend is an acellular dermal tissue matrix derived from bovine dermis. The device is suppl
10381780112792SurgiMend is an acellular dermal tissue matrix derived from bovine dermis. The device is suppl
10381780112785SurgiMend is an acellular dermal tissue matrix derived from bovine dermis. The device is suppl
10381780112778SurgiMend is an acellular dermal tissue matrix derived from bovine dermis. The device is suppl
10381780112761SurgiMend is an acellular dermal tissue matrix derived from bovine dermis. The device is suppl
10381780112747SurgiMend is an acellular dermal tissue matrix derived from bovine dermis. The device is suppl
10381780112723SurgiMend is an acellular dermal tissue matrix derived from bovine dermis. The device is suppl
10381780112716SurgiMend is an acellular dermal tissue matrix derived from bovine dermis. The device is suppl

Trademark Results [SurgiMend]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SURGIMEND
SURGIMEND
77243474 3408647 Live/Registered
TEI Biosciences Inc.
2007-07-31

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