DEVICE: BiValve Nasal Splint Thick (00385640000048)
Device Identifier (DI) Information
BiValve Nasal Splint Thick
SP-27005
In Commercial Distribution
SP-27005
SUMMIT MEDICAL, INC.
SP-27005
In Commercial Distribution
SP-27005
SUMMIT MEDICAL, INC.
No description.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
Yes | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
---|---|
Intranasal splint, non-biodegradable | A sterile, non-biodegradable device intended to be temporarily placed via a nostril into the nasal cavity after surgery or trauma to help minimize bleeding by tamponade effect, prevent adhesions between the mucosal surfaces, and provide support to the surrounding tissues during the healing period. It is typically made of plastic, silicone, and/or a blood/liquid absorptive material and is removed at the discretion of the physician. This is a single-use device. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
EPP | Splint, Nasal |
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
3330839a-ec35-4c79-bbf6-39a813dc0b69
March 29, 2018
2
August 09, 2016
March 29, 2018
2
August 09, 2016
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
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
888-229-2875
customerservice@summitmedicalusa.com
customerservice@summitmedicalusa.com