AccessGUDID - DEVICE: Terino Malar Shell® (M724TMSS41)

GUDID

Device Identifier (DI) Information

Brand Name: Terino Malar Shell®
Version or Model: Size: Small (4mm)
Commercial Distribution Status: In Commercial Distribution
Catalog Number: TMS-S4
Company Name: IMPLANTECH ASSOCIATES, INC.

Primary DI Number: M724TMSS41
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 784664955 *Terms of Use

Device Description: Malar 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?
45228	Malar prosthesis	An implantable device designed to augment or maintain the soft-tissue anatomy of the malar area (cheek). The device is typically a solid elastomer (e.g., silicone) available in several shapes and sizes for subdermal implantation in the malar area for cosmetic or reconstructive purposes following traumatic or disease/congenital deformation. This is a single-use device.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
LZK	Implant, Malar

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K901662	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: 3c150b38-3030-464b-a755-edcada12489d
Public Version Date: November 14, 2019
Public Version Number: 4
DI Record Publish Date: September 24, 2015