DEVICE: PrimeSight (04250480106402)

Device Identifier (DI) Information

PrimeSight
02-4307
In Commercial Distribution

SCHÖLLY FIBEROPTIC GmbH
04250480106402
GS1

1
316276682 *Terms of Use
Sinuscope 2.7 x 110 mm, 0°
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Device Characteristics

MR Unsafe
No
No
No
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
37180 Rigid optical 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 through relayed lens optics or a fibreoptic bundle. This is a reusable device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
EOB Nasopharyngoscope (Flexible Or Rigid)
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

No
Yes
Sterilization Method [?]
Hydrogen Peroxide
Moist Heat or Steam Sterilization
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Storage and Handling

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

[?]
Size Type Text
Device Size Text, specify: Insertion tube outer diameter 2.7 mm
Device Size Text, specify: Working length 110 mm
Device Size Text, specify: Direction of view 0 Degree
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Device Record Status

c2cc8151-07fa-4e1b-a26b-77496eecc751
November 17, 2023
3
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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