FOURTE Expander Fill System

Primary DI
10888628043602
Brand
FOURTE Expander Fill System
Company
Allergan, Inc.
Model
F-4444L
Catalog number
F-4444L
Device description
FOURTE Expander Fill System
Published
2019-01-14
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
LCJExpander, Skin, Inflatable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LCJTissue Expander And AccessoriesUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K161483000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K161483000Unger Quad InjectorStradis Healthcare2016-10-31LCJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10888628043602PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088862804360210888628043602

GMDN Terms#

Term, Definition table
TermDefinition
Tissue expander injection portA device designed for subcutaneous implantation and intended to be used temporarily to expand an implanted tissue expander by percutaneous injection of air or fluids (e.g., saline) typically over multiple expansion sessions. It consists of an auto-sealing port for needle puncture and a tube connector for attachment to the tissue expander. It is available in a variety of designs. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8006244261ProductSupport@allergan.com

Regulatory Flags#

DUNS number
144796497
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

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Primary DI, Brand, Model table
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10888628031579Natrelle Inspira ST Resterilizable SizersMSZST-L560MSZST-L5602016-10-05
10888628031586Natrelle Inspira ST Resterilizable SizersMSZST-L610MSZST-L6102017-03-20
10888628031593Natrelle Inspira ST Resterilizable SizersMSZST-LP125MSZST-LP1252016-10-05
10888628031609Natrelle Inspira ST Resterilizable SizersMSZST-LP145MSZST-LP1452016-10-05
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10888628031623Natrelle Inspira ST Resterilizable SizersMSZST-LP190MSZST-LP1902016-10-05

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