Natrelle 133S Tissue Expanders

Primary DI
10888628043909
Brand
Natrelle 133S Tissue Expanders
Company
Allergan, Inc.
Model
133S-MV-16-T
Catalog number
133S-MV-16-T
Device description
Natrelle TE Smooth 133S-MV-16-T (US)
Published
2019-03-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
LCJExpander, Skin, Inflatable

Product Code Classifications

CodeDeviceSpecialtyClass
LCJTissue Expander And AccessoriesUnknownU

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10888628043909PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1088862804390910888628043909

GMDN Terms

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.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Sterilization Methods

Method

Contacts

PhoneEmail
8006244261ProductSupport@allergan.com

Regulatory Flags

DUNS number
144796497
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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