FDA.reportPublic FDA data

ARTOURA Breast Tissue Expander

Primary DI
00081317009481
Brand
ARTOURA Breast Tissue Expander
Company
MENTOR TEXAS L.P.
Model
TEXP135RH
Catalog number
TEXP135RH
Device description
Textured, High Profile, Suture Tabs, Integral Injection Dome, 500cc
Published
2015-05-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LCJEXPANDER, SKIN, INFLATABLE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LCJTissue Expander And AccessoriesUnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00081317009481PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00081317009481000813170094810813170094810081317009481

GMDN Terms#

Term, Definition table
TermDefinition
Skin-port tissue expanderAn expandable device intended for implantation to temporarily enlarge tissue, typically the dimensions of a skin flap where there is insufficient tissue coverage to accommodate the volume of an implantable device (e.g., a breast implant), or for the revision of a scar or cutaneous defect. The device typically consists of an expansion envelope (e.g., silicone elastomer) with fill tube and an inflation valve, and is expanded percutaneously with air or fluid through a subcutaneous port accessed by a healthcare professional. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)235-5731xx@xx.xx

Regulatory Flags#

DUNS number
167450993
Device count
1
Kit
true
Lot or batch
true
Serial number
true
Expiration date on label
true
No natural rubber latex
true

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