AccessGUDID - DEVICE: Flowers Mandibular Glove® (M724FMGVXL1)

GUDID

Device Identifier (DI) Information

Brand Name: Flowers Mandibular Glove®
Version or Model: Size: X-Large
Commercial Distribution Status: In Commercial Distribution
Catalog Number: FMG-VXL
Company Name: IMPLANTECH ASSOCIATES, INC.

Primary DI Number: M724FMGVXL1
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 784664955 *Terms of Use

Device Description: Chin Implant

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 [?]
K905268	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

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: ccbdb0df-21fe-4344-92d0-efbf0673d25c
Public Version Date: November 14, 2019
Public Version Number: 4
DI Record Publish Date: September 24, 2015