DEVICE: PrimeSight (04250480106365)

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Device Identifier (DI) Information

PrimeSight
02-4319

SCHÖLLY FIBEROPTIC GmbH
04250480106365
GS1
1
Sinuscope 2.7 x 187 mm, 30°
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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
Rigid sinoscope An endoscope with a rigid inserted portion intended for the visual examination and treatment of the paranasal sinuses during an ear/nose/throat (ENT) intervention. It is inserted through a naris. 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

[?]
Product Code Product Code Name
EOB Nasopharyngoscope (Flexible Or Rigid)
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Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
Hydrogen Peroxide
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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 30 Degree
Device Size Text, specify: Working length 187 mm
Device Size Text, specify: Insertion tube outer diameter 2.7 mm
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Device Status

In Commercial Distribution
November 10, 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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