DEVICE: TRACOE® larynx (04035324044818)

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Device Identifier (DI) Information

TRACOE® larynx
REF 612-08

Tracoe medical GmbH
04035324044818
GS1
1
TRACOE stoma button Standard
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Device Characteristics

Labeling does not contain MRI Safety Information
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
Tracheostoma button A hollow device intended to be used routinely by a patient to prevent the narrowing of a tracheostoma during intermittent use of their tracheostomy or laryngectomy tube. It is a cylindrical synthetic polymer device designed for minimal intrusion beyond the tracheostomal orifice into which it is placed. This is a reusable device.
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FDA Product Code

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Product Code Product Code Name
KAC TUBE, LARYNGECTOMY
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Sterilization

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

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Storage and Handling
Special Storage Condition, Specify: Products must be stored in cool and dry location. Temporary storage for less or equal to 30 days at less or equal to +50 °C is possible. Protect product from sunlight and extreme cold.
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Clinically Relevant Size

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Size Type Text
Lumen/Inner Diameter: 8.0 Millimeter
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Device Status

In Commercial Distribution
January 14, 2016

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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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

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+49613691690
info@tracoe.com
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