AccessGUDID - DEVICE: Lateral Mandibular Angle™ (M724TMA0408LNS1)

GUDID

Device Identifier (DI) Information

Brand Name: Lateral Mandibular Angle™
Version or Model: Size: 4/8, Left
Commercial Distribution Status: In Commercial Distribution
Catalog Number: TMA-04-08L-NS
Company Name: IMPLANTECH ASSOCIATES, INC.

Primary DI Number: M724TMA0408LNS1
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 784664955 *Terms of Use

Device Description: Mandibular 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?
16047	Facial mandibular prosthesis	A sterile implantable device intended to be used in the functional reconstruction of non-joint mandibular (lower jaw) deficits. It is made of metal and/or polymeric materials.	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: 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: e8cb8bef-9a08-46f6-9081-24edca9232cd
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 24, 2015