ARTIA Reconstructive Tissue Matrix

Primary DI
M328CL1097P0
Brand
ARTIA Reconstructive Tissue Matrix
Company
LIFECELL CORPORATION
Model
CL1097P
Catalog number
CL1097P
Device description
ARTIA Reconstructive Tissue Matrix Perforated Contour Large
Published
2017-12-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FTMMesh, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FTMMesh, SurgicalGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K162752000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162752000ARTIA Reconstructive Tissue Matrix PerforatedLifecell Corporation2017-02-24FTM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M328CL1097P0PrimaryHIBCC0
00818410014445SecondaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00818410014445008184100144458184100144450818410014445

GMDN Terms#

Term, Definition table
TermDefinition
Multi-purpose surgical mesh, collagen, bioabsorbableA sterile, bioabsorbable, flat or three-dimensional (3-D) implantable material made from animal-derived collagen intended for multiple tissue defect repair/hernia reduction (e.g., inguinal, ventral/incisional, umbilical, femoral) applications including an extra-abdominal application(s) [e.g., plastic surgery, breast reconstruction]. It may also be used as a short-term scaffold for tissue regeneration. Disposable devices associated with implantation (e.g., introducer needles, trocars) may be included.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

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
M32805050030Conexa Reconstructive Tissue Matrix050500305050032015-09-17
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

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