DEVICE: Blom-Singer® Nasal Septal Perforation Sizing Tool (00848253004006)
Device Identifier (DI) Information
Blom-Singer® Nasal Septal Perforation Sizing Tool
SPT 002
In Commercial Distribution
SPT 002
Freudenberg Medical, LLC
SPT 002
In Commercial Distribution
SPT 002
Freudenberg Medical, LLC
The Nasal Septal Perforation Sizing Tool (NSPST) is a graded handheld device designed to measure nasal septal perforations. The device is available in oval and round configurations with gradations that coincide with the offered sizes of Blom-Singer® Nasal Septal Perforation Prostheses. The device provides a method for measurement of size and thickness of nasal perforations to aid in selection of the appropriate Blom-Singer® Nasal Septal Perforation Prosthesis. The NSPST is a single use, non-sterile, disposable, invasive, transient duration (<60mins) measuring accessory to the Blom-Singer Nasal Septal Perforation Prosthesis. Each will be packed in a sealed pouch, 5 sealed pouches in one carton box which is sold as 1 unit of SPT 002.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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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39987 | Nasal depth gauge, reusable |
A manual instrument designed for introduction into and measurement of the nasal cavities and paranasal sinuses during diagnostic and/or surgical procedures. It typically consists of a hand-held, slender, rod-like metallic device with a fine blunt distal end; the device usually includes rings (e.g., 3, 4, 5 mm) with calibrated diameters at its distal end to perform the measurements. This is a reusable device.
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FDA Product Code
[?]Product Code | Product Code Name |
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JYJ | Gauge, Measuring |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
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
a60d438f-43bc-41a3-aa5a-cc0e7ada14e0
March 24, 2025
1
March 14, 2025
March 24, 2025
1
March 14, 2025
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
[?]
800-477-5969
InHealth@inhealth.com
InHealth@inhealth.com