Home GUDID 10851452007010 AeroForm® Tissue Expander
Primary DI 10851452007010
Brand AeroForm® Tissue Expander
Company AIRXPANDERS INC
Model 400cc Small
Catalog number BR125-400
Published 2017-06-21
Public version status Update
Distribution status In Commercial Distribution
MRI safety MR Unsafe
Rx true
Sterile true
Single use true Product Codes# Code, Name table Code Name PQN Carbon dioxide gas controlled tissue expander
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class PQN Carbon Dioxide Gas Controlled Tissue Expander General, Plastic Surgery 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10851452007010 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 10851452007010 10851452007010
GMDN Terms# Term, Definition table Term Definition Remotely-controlled tissue expander A device intended for implantation to develop tissue (skin) coverage by intermittent expansion, which can be remotely controlled by the patient or physician, prior to the placement of a permanent breast implant. Expansion is achieved by electronic release of gas [e.g., carbon dioxide (CO2)] from a pressurized container within the device. It typically consists of an outer silicone shell, an inner gas barrier, a reservoir of gas with valve, and electronics. It is intended to remain in situ until desired expansion is achieved, when it is replaced with the breast implant. This is a single-use device.
Device Sizes# Type, Value, Unit table Type Value Unit Device Size Text, specify 0 Total Volume 400 Milliliter
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Temperature -20 Degrees Celsius 60 Degrees Celsius
Sterilization Methods# Method table Method Ethylene Oxide
Regulatory Flags# DUNS number 860020127 Device count 1 Serial number true Manufacturing date on label true Expiration date on label true No natural rubber latex true Sterilization required before use true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 10851452007027 AeroForm® Tissue Expander 600cc Medium BR140-600 2017-06-21 10851452007034 AeroForm® Tissue Expander 800cc Large BR155-800 2017-06-21 10851452007157 AeroForm® Dosage Controller V1.5 AF-DC-1 2017-06-21
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 10851452007157 AeroForm® Dosage Controller AIRXPANDERS INC PQN 2017-06-21 10851452007027 AeroForm® Tissue Expander AIRXPANDERS INC PQN 2017-06-21 10851452007034 AeroForm® Tissue Expander AIRXPANDERS INC PQN 2017-06-21
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