ARTIA Reconstructive Tissue Matrix CM1097

GUDID M328CM10970

ARTIA Reconstructive Tissue Matrix Contour Medium

LIFECELL CORPORATION

Multi-purpose surgical mesh, collagen, bioabsorbable

Primary Device ID	M328CM10970
NIH Device Record Key	e3986c61-9f4a-4e91-8b27-9e63265c279e
Commercial Distribution Status	In Commercial Distribution
Brand Name	ARTIA Reconstructive Tissue Matrix
Version Model Number	CM1097
Catalog Number	CM1097
Company DUNS	157224205
Company Name	LIFECELL CORPORATION
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	800-367-5737
Email	xx@xx.xx
Phone	800-367-5737
Email	xx@xx.xx
Phone	800-367-5737
Email	xx@xx.xx
Phone	800-367-5737
Email	xx@xx.xx
Phone	800-367-5737
Email	xx@xx.xx
Phone	800-367-5737
Email	xx@xx.xx
Phone	800-367-5737
Email	xx@xx.xx
Phone	800-367-5737
Email	xx@xx.xx
Phone	800-367-5737
Email	xx@xx.xx
Phone	800-367-5737
Email	xx@xx.xx
Phone	800-367-5737
Email	xx@xx.xx
Phone	800-367-5737
Email	xx@xx.xx
Phone	800-367-5737
Email	xx@xx.xx
Phone	800-367-5737
Email	xx@xx.xx
Phone	800-367-5737
Email	xx@xx.xx
Phone	800-367-5737
Email	xx@xx.xx
Phone	800-367-5737
Email	xx@xx.xx
Phone	800-367-5737
Email	xx@xx.xx
Phone	800-367-5737
Email	xx@xx.xx
Phone	800-367-5737
Email	xx@xx.xx
Phone	800-367-5737
Email	xx@xx.xx
Phone	800-367-5737
Email	xx@xx.xx
Phone	800-367-5737
Email	xx@xx.xx
Phone	800-367-5737
Email	xx@xx.xx
Phone	800-367-5737
Email	xx@xx.xx
Phone	800-367-5737
Email	xx@xx.xx
Phone	800-367-5737
Email	xx@xx.xx
Phone	800-367-5737
Email	xx@xx.xx
Phone	800-367-5737
Email	xx@xx.xx
Phone	800-367-5737
Email	xx@xx.xx
Phone	800-367-5737
Email	xx@xx.xx
Phone	800-367-5737
Email	xx@xx.xx
Phone	800-367-5737
Email	xx@xx.xx
Phone	800-367-5737
Email	xx@xx.xx
Phone	800-367-5737
Email	xx@xx.xx
Phone	800-367-5737
Email	xx@xx.xx
Phone	800-367-5737
Email	xx@xx.xx
Phone	800-367-5737
Email	xx@xx.xx
Phone	800-367-5737
Email	xx@xx.xx

Operating and Storage Conditions

Storage Environment Temperature	Between -8 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between -8 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between -8 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between -8 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between -8 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between -8 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between -8 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between -8 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between -8 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between -8 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between -8 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between -8 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between -8 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between -8 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between -8 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between -8 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between -8 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between -8 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between -8 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between -8 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between -8 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between -8 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between -8 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between -8 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between -8 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between -8 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between -8 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between -8 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between -8 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between -8 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between -8 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between -8 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between -8 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between -8 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between -8 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between -8 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between -8 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between -8 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between -8 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00818410014506 [Secondary]
HIBCC	M328CM10970 [Primary]

FDA Product Code

FTM	Mesh, Surgical

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	3
Public Version Date	2021-05-17
Device Publish Date	2016-10-28

On-Brand Devices [ARTIA Reconstructive Tissue Matrix]

M328CXL1097P0	ARTIA Reconstructive Tissue Matrix Perforated Contour Extra Large
M328CXL10970	ARTIA Reconstructive Tissue Matrix Contour Extra Large
M328CS1097P0	ARTIA Reconstructive Tissue Matrix Perforated Contour Small
M328CS10970	ARTIA Reconstructive Tissue Matrix Contour Small
M328CM1097P0	ARTIA Reconstructive Tissue Matrix Perforated Contour Medium
M328CM10970	ARTIA Reconstructive Tissue Matrix Contour Medium
M328CL1097P0	ARTIA Reconstructive Tissue Matrix Perforated Contour Large
M328CL10970	ARTIA Reconstructive Tissue Matrix Contour Large
M32816201097P0	ARTIA Reconstructive Tissue Matrix Perforated 16 cm X 20 cm
M328162010970	ARTIA Reconstructive Tissue Matrix 16 cm X 20 cm
M328101610970	ARTIA Reconstructive Tissue Matrix 10 cm x 16 cm
M328082010970	ARTIA Reconstructive Tissue Matrix 8 cm x 20 cm
M328081610970	ARTIA Reconstructive Tissue Matrix 8 cm x 16 cm
M328061610970	ARTIA Reconstructive Tissue Matrix 6 cm x 16 cm