DEVICE: Otoscope (B366OT0330100R000)

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Device Identifier (DI) Information

Otoscope
R00
OT0330100
Ecleris
B366OT0330100R000
HIBCC
1
Otoscope 3mm Ø, 30°, 100mm L
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
No
No
No
No

GMDN

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

GMDN Preferred Term Name GMDN Definition
Rigid otoscope An endoscope with a rigid inserted portion intended to be used in otology, mainly for observation, diagnosis, and treatment of the middle ear. Anatomical images are transmitted to the user by the device through relayed lens optics or a fibreoptic bundle. This is a reusable device.
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FDA Product Code

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Product Code Product Code Name
ERA Otoscope
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Sterilization

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

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Storage and Handling
Storage Environment Temperature: between -10 and 40 Degrees Celsius
Storage Environment Humidity: between 19 and 90 Percent (%) Relative Humidity
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
September 24, 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

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No
Yes
No
Yes
No CLOSE

Customer Contact

[?]
7864837490
carlosb@ecleris.com
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