AccessGUDID - DEVICE: Sterile Micro Needle ELLISYS ST (08809495930777)

GUDID

Device Identifier (DI) Information

Brand Name: Sterile Micro Needle ELLISYS ST
Version or Model: CWM-930S_ELLISYS ST-S25
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Chungwoo Co., Ltd.

Primary DI Number: 08809495930777
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 689894533 *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":	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?
63582	Resective skin contouring/liposuction system needle/cannula kit	A collection of devices intended to be used to tighten loose or wrinkled skin and, optionally, cosmetically remove fat, through rotational force and suction provided by a dedicated console. It consists of a multiple coring needle array used to create a matrix of small circular holes in the skin which subsequently heal with contraction, a lipectomy cannula to be inserted subcutaneously into the fat layer for the aspiration of adipose tissue (fat), and a single coring needle for creating an opening in the skin for insertion of the lipectomy cannula. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GEI	Electrosurgical, Cutting & Coagulation & Accessories

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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: 7d5adbd1-b04a-4ec5-a279-c4b1e2b163eb
Public Version Date: September 03, 2024
Public Version Number: 2
DI Record Publish Date: June 25, 2024