DEVICE: Spectrum Designs Medical (B018250734S1)

Device Identifier (DI) Information

Spectrum Designs Medical
Mittelman Geniomandibular Groove Jowl, size 3
In Commercial Distribution
250-734S
SPECTRUM DESIGNS INC
B018250734S1
HIBCC

1
148681521 *Terms of Use
Allergan Distributed
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
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
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.
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FDA Product Code

[?]
Product Code Product Code Name
FWP Prosthesis, Chin, Internal
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

96b0a3a6-9d46-42e7-804e-7b78147d134d
March 29, 2018
2
October 23, 2015
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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
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
Yes
Yes
Yes
No CLOSE

Customer Contact

[?]
8056847678
service@spectrumdesignsmedical.com
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