AccessGUDID - DEVICE: Composite™ ePTFE-Coated Auricular Anti-Helix (M724EPTFEAAH58L1)

GUDID

Device Identifier (DI) Information

Brand Name: Composite™ ePTFE-Coated Auricular Anti-Helix
Version or Model: Size 58, Left
Commercial Distribution Status: In Commercial Distribution
Catalog Number: EPTFE-AAH-58L
Company Name: IMPLANTECH ASSOCIATES, INC.

Primary DI Number: M724EPTFEAAH58L1
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 784664955 *Terms of Use

Device Description: Auricular 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":	Yes
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?
35262	External ear prosthesis, implantable	A device intended to be fully- or partially- implanted to reconstruct the external ear by replacing damaged or missing tissue. It is typically made of a polymer material (e.g., solid silicone rubber).	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
FZD	Prosthesis, Ear, Internal

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K172389	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: 976fe9d8-70c6-43a9-89a7-1811f6efa8cd
Public Version Date: July 14, 2023
Public Version Number: 1
DI Record Publish Date: July 06, 2023