Austin / Polycel®

Basic Information

• Brand Name: Austin / Polycel®
• Primary DI: 00763000035440
• Version / Model: 1156361
• Company Name: MEDTRONIC XOMED, INC.
• Labeler DUNS: 835465063
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-11-07
• Public Version: 1
• Public Version Date: 2021-11-15
• Public Version Status: New
• Public Device Record Key: 09bef27a-cbb3-4cce-bd29-14f66456020c

Device Description

PROSTHESIS 1156361 AUSTIN OFFSET PARTIAL

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: No
• MRI Safety: MR Safe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• 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
LBM	POROUS POLYETHYLENE OSSICULAR REPLACEMENT	Ear, Nose, Throat	874.3450	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35690	Ossicular prosthesis, partial	A sterile device intended to be implanted for the functional reconstruction of segments of the ossicular chain (mallues, incus, and/or stapes bones) to facilitate the conduction of sound waves from the tympanic membrane to the inner ear. It is designed to treat conductive hearing loss from traumatic or surgical injury, otosclerosis, congenital fixation of the stapes, or chronic middle ear disease. The device is typically in the form of a tube made of metal [e.g., stainless steel, titanium (Ti)], polymers, or a combination of these materials.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00763000035440	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K823441	000

Device Sizes

Type	Value	Unit	Text
Length	4.75	Millimeter
Device Size Text, specify			Head Diameter = 3 mm
Device Size Text, specify			Shaft Inner Diameter = 1.17 mm