Vent. Tube Long-Term,1 Eye Gold-Platinum

Basic Information

• Brand Name: Vent. Tube Long-Term,1 Eye Gold-Platinum
• Primary DI: EHKM10150641
• Version / Model: 1015064
• Catalog Number: 1015064
• Company Name: Heinz Kurz GmbH
• Labeler DUNS: 341155720
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-09-21
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 849acf82-9885-4b76-b738-736eae88f7dd

Device Description

Middle ear implantable mould

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 Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
ETD	Tube, Tympanostomy	Ear, Nose, Throat	874.3880	2

GMDN Terms

Code	Name	Definition	Implantable	Status
31934	Middle ear moulding	A preformed device intended to be implanted to reconstruct the middle ear cavity during repair of the tympanic membrane by permitting an ample air-filled cavity to be maintained in the middle ear; it also promotes regeneration of the mucous membrane lining of the middle ear cavity. It is typically made of synthetic polymer materials [e.g., polyamide, polytetrafluoroethylene (PTFE), silicone elastomer or polyethylene (PE)].	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	EHKM10150641	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K973226	000