DEVICE: NA (00385640002417)
Device Identifier (DI) Information
Device Characteristics
MR Conditional | |
No | |
Yes | |
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 |
---|---|
Tympanostomy tube | A small, hollow cylinder intended to be implanted, by insertion through the tympanic membrane, for ventilation or drainage of the middle ear. Otherwise known as a grommet, it is made of materials such as polytetrafluoroethylene (PTFE), polyethylene (PE), silicon elastomer, or porous polyethylene. One type, known as the malleous clip tube, attaches to the malleolus. Disposable devices associated with implantation may be included, which may be used to implant bilateral tubes. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
ETD | Tube, Tympanostomy |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K830228 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
431e48e9-60ce-4a8e-9401-56850ce2ce4b
July 06, 2018
3
September 16, 2016
July 06, 2018
3
September 16, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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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
[?]
No Customer Contact currently defined