MEDPOR

Basic Information

• Brand Name: MEDPOR
• Primary DI: 07613252085027
• Version / Model: 8328
• Catalog Number: 8328
• Company Name: Stryker Leibinger GmbH & Co. KG
• Labeler DUNS: 316153956
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-09-24
• Public Version: 5
• Public Version Date: 2021-07-22
• Public Version Status: Update
• Public Device Record Key: 5c0ea762-57d7-4f3f-ae69-6bd7861fa600

Device Description

Helical Rim - Right

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: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FWP	PROSTHESIS, CHIN, INTERNAL	General, Plastic Surgery	878.3550	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35262	External ear prosthesis, implantable	A device intended to be fully- or partially- implanted to reconstruct the external ear by replacing damaged or missing tissue. It is typically made of a polymer material (e.g., solid silicone rubber).	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07613252085027	GS1

Premarket Submissions

Submission Number	Supplement Number
K922489	000

Device Sizes

Type	Value	Unit	Text
Length	62.0	Millimeter
Width	37.0	Millimeter