AccessGUDID - DEVICE: Euromi (03701416200301)

GUDID

Device Identifier (DI) Information

Brand Name: Euromi
Version or Model: 1214LMEW-3250
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1214LMEW-3250
Company Name: Euromi

Primary DI Number: 03701416200301
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 505804302 *Terms of Use

Device Description: The cannulas are reusable medical devices intended to be used by healthcare professionals for surgical or aesthetic applications. They are designed for the injection, irrigation, or aspiration of biological fluids, depending on their configuration. Manufactured from stainless steel or tungsten, they provide excellent mechanical and chemical resistance, ensuring durability and compatibility with standard cleaning, disinfection, and sterilization processes commonly used in the medical field. The cannulas are supplied non-sterile and must be thoroughly cleaned and sterilized before each use. They are available in various lengths, diameters, and tip configurations depending on the intended use, and are designed to ensure precise, safe, and comfortable handling.

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:	No
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?
45414	Liposuction system cannula, reusable	A rigid tube that functions as a component of a lipectomy suction system and designed specifically for percutaneous insertion into body fat deposits for the aspiration of fat during liposuction/lipoplasty. The device may also be used to infiltrate the operative site with a solution during the procedure, which is then aspirated. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GEA	Cannula, Surgical, General & Plastic Surgery

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K010311	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: a8fdbafd-d07d-4750-be20-00d822acd36c
Public Version Date: October 17, 2025
Public Version Number: 1
DI Record Publish Date: October 09, 2025