AlloX2 Magnetic Site Locator

Basic Information

• Brand Name: AlloX2 Magnetic Site Locator
• Primary DI: 00819409020409
• Version / Model: AMSL01
• Catalog Number: AMSL01
• Company Name: Sientra, Inc.
• Labeler DUNS: 010209877
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-03-28
• Public Version: 2
• Public Version Date: 2023-10-25
• Public Version Status: Update
• Public Device Record Key: aab9a663-ec3a-4f37-905a-d66c921c5af4

Device Description

AlloX2 Magnetic Site Locator (5 each)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LCJ	Expander, Skin, Inflatable	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
46583	Tissue expander injection port locator	A small, hand-held, manually-operated, sterile device designed to assist with the location of the subcutaneous injection port of an implanted tissue expander prior to the insertion of a filling needle into the port in order to fill the tissue expander with, e.g., saline. It is moved over the surface of the skin at the point where the concealed injection site is situated and an indicator, e.g., a small magnet, reacts to the metal material of the port, indicating where it is located. Repetition of this locating process on several axes provides the exact location of the injection site. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00819409020409	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K140383	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Not applicable