DEVICE: Spectrum Designs Medical (B018S400514S1)
Device Identifier (DI) Information
Spectrum Designs Medical
Dorsal Columella, Style 5, size 1
In Commercial Distribution
S400-514S
SPECTRUM DESIGNS INC
Dorsal Columella, Style 5, size 1
In Commercial Distribution
S400-514S
SPECTRUM DESIGNS INC
No description.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
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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? |
---|---|---|---|---|
31038 | Nasal cartilage support implant, non-bioabsorbable |
A non-bioabsorbable device intended to be implanted beneath the skin of the nose (e.g., between the nasal mucosa and the cartilage) to augment or restore the cosmetic appearance and/or function of the nose, by providing structural support to the cartilage. It is a shaped device made of synthetic polymer materials (e.g., solid silicone rubber).
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Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
FZE | Prosthesis, Nose, Internal |
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
660f1b14-29ac-410a-bf9c-3106fc5fca1d
March 05, 2024
3
October 23, 2015
March 05, 2024
3
October 23, 2015
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
[?]
8056847678
service@spectrumdesignsmedical.com
service@spectrumdesignsmedical.com