Strattice Reconstructive Tissue Matrix BPS 0808006

GUDID M32808080060

BPS Strattice 8 cm x 8 cm - Pliable

LIFECELL CORPORATION

Multi-purpose surgical mesh, collagen, bioabsorbable
Primary Device IDM32808080060
NIH Device Record Key35cf898e-bba3-40bc-8626-b52e5fb93afe
Commercial Distribution StatusIn Commercial Distribution
Brand NameStrattice Reconstructive Tissue Matrix BPS
Version Model Number0808006
Catalog Number0808006
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

Device Dimensions

Length8 Centimeter
Width8 Centimeter
Length8 Centimeter
Width8 Centimeter
Length8 Centimeter
Width8 Centimeter
Length8 Centimeter
Width8 Centimeter
Length8 Centimeter
Width8 Centimeter
Length8 Centimeter
Width8 Centimeter
Length8 Centimeter
Width8 Centimeter
Length8 Centimeter
Width8 Centimeter
Length8 Centimeter
Width8 Centimeter
Length8 Centimeter
Width8 Centimeter
Length8 Centimeter
Width8 Centimeter
Length8 Centimeter
Width8 Centimeter
Length8 Centimeter
Width8 Centimeter
Length8 Centimeter
Width8 Centimeter
Length8 Centimeter
Width8 Centimeter
Length8 Centimeter
Width8 Centimeter
Length8 Centimeter
Width8 Centimeter
Length8 Centimeter
Width8 Centimeter
Length8 Centimeter
Width8 Centimeter
Length8 Centimeter
Width8 Centimeter
Length8 Centimeter
Width8 Centimeter
Length8 Centimeter
Width8 Centimeter
Length8 Centimeter
Width8 Centimeter
Length8 Centimeter
Width8 Centimeter
Length8 Centimeter
Width8 Centimeter
Length8 Centimeter
Width8 Centimeter
Length8 Centimeter
Width8 Centimeter
Length8 Centimeter
Width8 Centimeter
Length8 Centimeter
Width8 Centimeter
Length8 Centimeter
Width8 Centimeter
Length8 Centimeter
Width8 Centimeter
Length8 Centimeter
Width8 Centimeter
Length8 Centimeter
Width8 Centimeter
Length8 Centimeter
Width8 Centimeter
Length8 Centimeter
Width8 Centimeter
Length8 Centimeter
Width8 Centimeter
Length8 Centimeter
Width8 Centimeter
Length8 Centimeter
Width8 Centimeter
Length8 Centimeter
Width8 Centimeter

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
GS100818410010256 [Secondary]
HIBCCM32808080060 [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.