DEVICE: FIBER LARYNGOSCOPE (04961333232772)
Device Identifier (DI) Information
FIBER LARYNGOSCOPE
FNL-10RP3
In Commercial Distribution
PENTAX OF AMERICA, INC.
FNL-10RP3
In Commercial Distribution
PENTAX OF AMERICA, INC.
FIBER NASO PHARYNGO LARYNGOSCOPE (REFURBISHED)
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No |
GMDN
[?]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? |
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44715 | Flexible fibreoptic nasopharyngolaryngoscope |
An endoscope with a flexible inserted portion intended for the visual examination and treatment of the structures inside the nasal passages, including the sinus openings, the pharyngeal end of the auditory tube, the larynx, and the vocal cords. It is inserted through a nostril and typically provides the operator with greater manoeuvrability (flexibility of the distal end) for improved viewing during nasopharyngolaryngoscopy. Anatomical images are transmitted to the user by the device through a fibreoptic bundle. This is a reusable device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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EOB | Nasopharyngoscope (Flexible Or Rigid) |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K951196 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
94e284e4-1ca1-4035-a5cd-9796065cc91d
July 06, 2018
3
April 06, 2017
July 06, 2018
3
April 06, 2017
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined