DEVICE: Partial Middle Ear Implant (04250381805244)
Device Identifier (DI) Information
Partial Middle Ear Implant
12917
In Commercial Distribution
12917
Spiggle & Theis Medizintechnik GmbH
12917
In Commercial Distribution
12917
Spiggle & Theis Medizintechnik GmbH
Partial middle ear implant, fixed size, titanium, round-centric head, unslit bell, 1.75x0.3 mm, sterile
Device Characteristics
MR Conditional | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
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.
|
Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
ETB | Prosthesis, Partial Ossicular Replacement |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K030492 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: Storage must protect from dust, moisture and contamination. Avoid direct sunlight during storage. |
Clinically Relevant Size
[?]Size Type Text |
---|
Length: 1.75 Millimeter |
Device Record Status
6fcfb74e-2280-4899-8442-fafc9dbdfa64
July 06, 2018
3
December 04, 2015
July 06, 2018
3
December 04, 2015
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+49220690810
info@spiggle-theis.de
info@spiggle-theis.de