FDA.reportPublic FDA data

Conexa Reconstructive Tissue Matrix

Primary DI
M32805050030
Brand
Conexa Reconstructive Tissue Matrix
Company
LIFECELL CORPORATION
Model
0505003
Catalog number
0505003
Device description
Conexa 5cm x 5cm Thick Pliable Product, Rotator Cuff
Published
2015-09-17
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FTLMesh, Surgical, Polymeric

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FTLMesh, Surgical, PolymericGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M32805050030PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Extra-gynaecological surgical mesh, collagen, bioabsorbableA bioabsorbable, implantable material (e.g., flat sheet) made from animal-derived collagen intended for extra-gynaecological, non-dental tissue repair/reinforcement application(s) [e.g., pericardial reinforcement, plastic surgery, abdominal hernia repair]. It is constructed of cross-linked collagen (e.g., with glutaraldehyde) and may also be intended as a short-term scaffold for tissue regeneration. Disposable devices associated with implantation may be supplied with the mesh.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length5Centimeter
Width5Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-8 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-367-5737xx@xx.xx

Regulatory Flags#

DUNS number
157224205
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M32802040040Conexa Reconstructive Tissue Matrix020400402040042015-09-17
M32803030030Conexa Reconstructive Tissue Matrix030300303030032015-09-17
M32804040040Conexa Reconstructive Tissue Matrix040400404040042015-09-17
M32805100030Conexa Reconstructive Tissue Matrix051000305100032015-09-17
M32805100040Conexa Reconstructive Tissue Matrix051000405100042015-09-17
M32806060040Conexa Reconstructive Tissue Matrix060600406060042015-09-17
M32803140060Strattice Reconstructive Tissue Matrix BPS031400603140062015-09-17
M32804160060Strattice Reconstructive Tissue Matrix BPS041600604160062015-09-17
M32805160010Strattice Reconstructive Tissue Matrix051600105160012015-09-17
M32806060020Strattice Reconstructive Tissue Matrix060600206060022015-09-17
M32806080010Strattice Reconstructive Tissue Matrix060800106080012015-09-17
M32806080050Strattice Reconstructive Tissue Matrix Laparoscopic060800506080052015-09-17
M32806100080Strattice Reconstructive Tissue Matrix061000806100082015-09-17
M32806130090Strattice Reconstructive Tissue Matrix061300906130092015-09-17
M32806160020Strattice Reconstructive Tissue Matrix061600206160022015-09-17
M328061610970ARTIA Reconstructive Tissue Matrix06161097061610972016-10-28
M32808080020Strattice Reconstructive Tissue Matrix080800208080022015-09-17
M32808080060Strattice Reconstructive Tissue Matrix BPS080800608080062015-09-17
M32808150090Strattice Reconstructive Tissue Matrix081500908150092015-09-17
M32808160010Strattice Reconstructive Tissue Matrix081600108160012015-09-17

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Primary DI, Brand, Company table
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