DEVICE: VIDEO NASO PHARYNGO LARYNGOSTROBOSCOPE (04961333233960)

Device Identifier (DI) Information

VIDEO NASO PHARYNGO LARYNGOSTROBOSCOPE
VNL-1570STK
In Commercial Distribution

PENTAX OF AMERICA, INC.
04961333233960
GS1

1
083211284 *Terms of Use
VIDEO NASO PHARYNGO LARYNGOSTROBOSCOPE (REFURBISHED)
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Device Characteristics

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

GMDN

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GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
35462 Flexible video laryngoscope
An endoscope with a flexible inserted portion intended for the visual examination and treatment of the larynx. It is inserted into the body through the mouth during laryngoscopy. Anatomical images are transmitted to the user by a video system at the distal end of the endoscope with the images showing on a monitor. This device is commonly used to evaluate or operate on laryngeal strictures, foreign bodies, or neoplasms; it is not intended for intubation of an artificial airway. This is a reusable device.
Active false
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FDA Product Code

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

FDA Premarket Submission Number [?] Supplement Number [?]
K162151 000
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Sterilization

No
Yes
Sterilization Method [?]
Liquid Chemical
High-level Disinfectant
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

0983723f-bd8a-427c-8e26-629687e0767a
July 06, 2018
3
June 26, 2017
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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
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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