DEVICE: Partial Middle Ear Implant (04250381804582)

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Device Identifier (DI) Information

Partial Middle Ear Implant
12100
12100
Spiggle & Theis Medizintechnik GmbH
04250381804582
GS1
1
Partial middle ear implant, shortenable, titanium, with head, 5.5x0.3 mm, sterile
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Device Characteristics

MR Conditional
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
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.
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FDA Product Code

[?]
Product Code Product Code Name
ETB Prosthesis, Partial Ossicular Replacement
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Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: Storage must protect from dust, moisture and contamination. Avoid direct sunlight during storage.
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Clinically Relevant Size

[?]
Size Type Text
Length: 5.5 Millimeter
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Device Status

In Commercial Distribution
December 04, 2015

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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
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+49220690810
info@spiggle-theis.de
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