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
00848253004006
GS1

1
120981337 *Terms of Use
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.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
No
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. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
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.
Active false
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FDA Product Code

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Product Code Product Code Name
JYJ Gauge, Measuring
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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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

a60d438f-43bc-41a3-aa5a-cc0e7ada14e0
March 24, 2025
1
March 14, 2025
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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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Yes
No
Yes
No
No CLOSE

Customer Contact

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800-477-5969
InHealth@inhealth.com
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