AccessGUDID - DEVICE: AART Nasal Implant Sizer (B4904022022A0)

GUDID

Device Identifier (DI) Information

Brand Name: AART Nasal Implant Sizer
Version or Model: A
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 402-202-2A
Company Name: Aart

Primary DI Number: B4904022022A0
Issuing Agency: HIBCC
Commercial Distribution End Date: July 22, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 091356894 *Terms of Use

Device Description: Szr - Nasal Sty 2 NS

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):	No
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?
31038	Nasal cartilage support implant, non-bioabsorbable	A non-bioabsorbable device intended to be implanted beneath the skin of the nose (e.g., between the nasal mucosa and the cartilage) to augment or restore the cosmetic appearance and/or function of the nose, by providing structural support to the cartilage. It is a shaped device made of synthetic polymer materials (e.g., solid silicone rubber).	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
FZE	PROSTHESIS, NOSE, INTERNAL

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K021418	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Dry Heat 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: 66a2a87a-5ad3-4bc7-b75b-cbc9c1a6edde
Public Version Date: August 18, 2025
Public Version Number: 5
DI Record Publish Date: December 20, 2016