DEVICE: PrimeSight (04250480107324)

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Device Identifier (DI) Information

PrimeSight
02-4304

SCHÖLLY FIBEROPTIC GmbH
04250480107324
GS1
1
Otoscope 2.7 x 34 mm, 0°
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Device Characteristics

MR Unsafe
No
No
No
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
Otoscope, endoscopic An endoscope with a rigid inserted portion intended to be used in otology mainly for observation, diagnosis, and treatment of the outer and/or middle ear. Anatomical images are transmitted to the user by the device through relayed lens optics or a fibreoptic bundle typically with images displayed on a monitor. This is a reusable device.
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FDA Product Code

[?]
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

[?]
Storage and Handling
Storage Environment Temperature: between -20 and 70 Degrees Celsius
Storage Environment Humidity: between 5 and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 70 and 106 KiloPascal
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Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: Direction of view 0 Degree
Device Size Text, specify: Working length 34 mm
Device Size Text, specify: Insertion tube outer diameter 2.7 mm
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Device Status

In Commercial Distribution
December 05, 2016

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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

[?]
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

[?]
No
Yes
No
Yes
No CLOSE

Customer Contact

[?]
9999999999
info@schoelly-usa.com
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