AccessGUDID - DEVICE: AYON Infiltration Handle on/off (00607151050535)

GUDID

Device Identifier (DI) Information

Brand Name: AYON Infiltration Handle on/off
Version or Model: AYON-IF-0002
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: APYX MEDICAL CORPORATION

Primary DI Number: 00607151050535
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 101223287 *Terms of Use

Device Description: No description.

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:	No
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?
36894	Liposuction system	An assembly of devices designed specifically to aspirate subcutaneous fat from the body by means of suction during a liposuction/lipectomy procedure. The system consists of an electrically-powered suction pump, typically with collection containers, tubing, and microbial/hydrophobic filters, and includes patient contact devices (e.g., handpiece/tip, cannula). The pump generates negative pressure for aspiration of fat through the patient contact device, which is inserted subcutaneously into the fat layer, and into the collection containers.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QPB	System, Suction, Lipoplasty For Removal

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K244050	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: 3c58a57a-84d5-4cc4-b23b-9130e61f2acc
Public Version Date: June 06, 2025
Public Version Number: 1
DI Record Publish Date: May 29, 2025