Strattice Reconstructive Tissue Matrix BPS CON3006

GUDID M328CON30060

Large Curved Shape for Strattice, BPS (Contour3)

LIFECELL CORPORATION

Multi-purpose surgical mesh, collagen, bioabsorbable Multi-purpose surgical mesh, collagen, bioabsorbable Multi-purpose surgical mesh, collagen, bioabsorbable Multi-purpose surgical mesh, collagen, bioabsorbable Multi-purpose surgical mesh, collagen, bioabsorbable Multi-purpose surgical mesh, collagen, bioabsorbable Multi-purpose surgical mesh, collagen, bioabsorbable Multi-purpose surgical mesh, collagen, bioabsorbable Multi-purpose surgical mesh, collagen, bioabsorbable Multi-purpose surgical mesh, collagen, bioabsorbable Multi-purpose surgical mesh, collagen, bioabsorbable Multi-purpose surgical mesh, collagen, bioabsorbable Multi-purpose surgical mesh, collagen, bioabsorbable Multi-purpose surgical mesh, collagen, bioabsorbable Multi-purpose surgical mesh, collagen, bioabsorbable 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 IDM328CON30060
NIH Device Record Key366597cd-a8a2-4a72-b42f-f8a32c0a956b
Commercial Distribution StatusIn Commercial Distribution
Brand NameStrattice Reconstructive Tissue Matrix BPS
Version Model NumberCON3006
Catalog NumberCON3006
Company DUNS157224205
Company NameLIFECELL CORPORATION
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

Phone800-367-5737
Emailxx@xx.xx
Phone800-367-5737
Emailxx@xx.xx
Phone800-367-5737
Emailxx@xx.xx
Phone800-367-5737
Emailxx@xx.xx
Phone800-367-5737
Emailxx@xx.xx
Phone800-367-5737
Emailxx@xx.xx
Phone800-367-5737
Emailxx@xx.xx
Phone800-367-5737
Emailxx@xx.xx
Phone800-367-5737
Emailxx@xx.xx
Phone800-367-5737
Emailxx@xx.xx
Phone800-367-5737
Emailxx@xx.xx
Phone800-367-5737
Emailxx@xx.xx
Phone800-367-5737
Emailxx@xx.xx
Phone800-367-5737
Emailxx@xx.xx
Phone800-367-5737
Emailxx@xx.xx
Phone800-367-5737
Emailxx@xx.xx
Phone800-367-5737
Emailxx@xx.xx
Phone800-367-5737
Emailxx@xx.xx
Phone800-367-5737
Emailxx@xx.xx
Phone800-367-5737
Emailxx@xx.xx
Phone800-367-5737
Emailxx@xx.xx
Phone800-367-5737
Emailxx@xx.xx
Phone800-367-5737
Emailxx@xx.xx
Phone800-367-5737
Emailxx@xx.xx
Phone800-367-5737
Emailxx@xx.xx
Phone800-367-5737
Emailxx@xx.xx
Phone800-367-5737
Emailxx@xx.xx
Phone800-367-5737
Emailxx@xx.xx
Phone800-367-5737
Emailxx@xx.xx
Phone800-367-5737
Emailxx@xx.xx
Phone800-367-5737
Emailxx@xx.xx
Phone800-367-5737
Emailxx@xx.xx
Phone800-367-5737
Emailxx@xx.xx
Phone800-367-5737
Emailxx@xx.xx
Phone800-367-5737
Emailxx@xx.xx
Phone800-367-5737
Emailxx@xx.xx
Phone800-367-5737
Emailxx@xx.xx
Phone800-367-5737
Emailxx@xx.xx
Phone800-367-5737
Emailxx@xx.xx

Operating and Storage Conditions

Storage Environment TemperatureBetween -8 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -8 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -8 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -8 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -8 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -8 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -8 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -8 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -8 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -8 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -8 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -8 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -8 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -8 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -8 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -8 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -8 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -8 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -8 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -8 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -8 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -8 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -8 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -8 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -8 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -8 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -8 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -8 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -8 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -8 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -8 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -8 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -8 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -8 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -8 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -8 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -8 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -8 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -8 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100818410010294 [Secondary]
HIBCCM328CON30060 [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 Date2021-05-17
Device Publish Date2015-09-17

On-Brand Devices [Strattice Reconstructive Tissue Matrix BPS]

M328CON30060Large Curved Shape for Strattice, BPS (Contour3)
M328CON20060Medium Curved Shape for Strattice, BPS (Contour2)
M328CON10060Small curved shape for Strattice, BPS (Contour 1)
M32810160060BPS Strattice 10 cm x 16 cm - Pliable
M32808080060BPS Strattice 8 cm x 8 cm - Pliable
M32804160060BPS Strattice 4 cm x 16 cm - Pliable
M32803140060BPS Strattice 3 cm x 14 cm - Pliable

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