DEVICE: ePTFE Extended Chin (M724ESECL1)
Device Identifier (DI) Information
ePTFE Extended Chin
Size: Large
In Commercial Distribution
ESEC-L
IMPLANTECH ASSOCIATES, INC.
Size: Large
In Commercial Distribution
ESEC-L
IMPLANTECH ASSOCIATES, INC.
Chin Implant
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? |
---|---|---|---|---|
35261 | Chin prosthesis |
A sterile device implanted in the soft tissue of the chin to correct chin deformities or improve facial appearance. It is usually made of a polymer material.
|
Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
FWP | Prosthesis, Chin, Internal |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K141027 | 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
e3caebdc-133b-4c9b-86cd-63c636995178
November 15, 2019
2
June 14, 2019
November 15, 2019
2
June 14, 2019
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
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