AccessGUDID - DEVICE: Vertical Lengthening Chin Sizers (M724VLCSIZNS1)

GUDID

Device Identifier (DI) Information

Brand Name: Vertical Lengthening Chin Sizers
Version or Model: VLC-SIZ
Commercial Distribution Status: In Commercial Distribution
Catalog Number: VLC-SIZ-NS
Company Name: IMPLANTECH ASSOCIATES, INC.

Primary DI Number: M724VLCSIZNS1
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 784664955 *Terms of Use

Device Description: Chin Sizers

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

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 [?]
K904657	000
K911516	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d6a58058-f15d-4b49-b6b3-4aed9063b0e9
Public Version Date: February 10, 2022
Public Version Number: 5
DI Record Publish Date: October 17, 2017