Total Middle Ear Implant

Basic Information

• Brand Name: Total Middle Ear Implant
• Primary DI: 04250381804261
• Version / Model: 11955
• Catalog Number: 11955
• Company Name: Spiggle & Theis Medizintechnik GmbH
• Labeler DUNS: 332893028
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-12-04
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 9c9021b7-7859-402e-8214-2e7684568c9b

Device Description

Total middle ear implant, fixed size, titanium round-centric head, 5.5x0.3 mm, sterile

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
ETA	Replacement, Ossicular Prosthesis, Total	Ear, Nose, Throat	874.3495	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35674	Ossicular prosthesis, total	A sterile device intended to be implanted for the total functional reconstruction of the ossicular chain (mallues, incus, and 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 polymers.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04250381804261	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K030492	000

Device Sizes

Type	Value	Unit	Text
Length	5.5	Millimeter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Storage must protect from dust, moisture and contamination. Avoid direct sunlight during storage.