MEDPOR

Basic Information

• Brand Name: MEDPOR
• Primary DI: 07613252084006
• Version / Model: 7545
• Catalog Number: 7545
• 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: 3
• Public Version Date: 2020-10-12
• Public Version Status: Update
• Public Device Record Key: 46a46784-60a6-4468-a894-7af809a1d5fd

Device Description

Lateral Nasal Valve

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
31038	Nasal implant, synthetic polymer, non-bioabsorbable	A non-bioabsorbable device intended to be implanted beneath the skin of the nose (e.g., between the nasal mucosa and the cartilage) to augment or restore the cosmetic appearance and/or function of the nose, by providing structural support to the cartilage. It is a shaped device made of synthetic polymer materials (e.g., solid silicone rubber).	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07613252084006	GS1
Package	37613252084007	GS1	pack	2	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
K922489	000

Device Sizes

Type	Value	Unit	Text
Height	3.5	Millimeter
Device Size Text, specify			Diameter: 13.0 Millimeter
Device Size Text, specify			Thickness: 0.85 Millimeter