DEVICE: 900-020 Dorsal Columella Syle 2 Sizer Set (M7249000201)
Device Identifier (DI) Information
900-020 Dorsal Columella Syle 2 Sizer Set
900-020
In Commercial Distribution
900-020
IMPLANTECH ASSOCIATES, INC.
900-020
In Commercial Distribution
900-020
IMPLANTECH ASSOCIATES, INC.
Nasal Sizer Set
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
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? |
---|---|---|---|---|
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 [?] |
---|---|
K944166 | 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
d12913f8-bc54-4ceb-a54d-85a6b7c73132
March 05, 2024
2
July 20, 2021
March 05, 2024
2
July 20, 2021
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
[?]
1-800-733-0833
info@implantech.com
info@implantech.com