AccessGUDID - DEVICE: AGNES-S (18800067700016)

GUDID

Device Identifier (DI) Information

Brand Name: AGNES-S
Version or Model: AGNES-S
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: AGNES MEDICAL CO., LTD.

Primary DI Number: 18800067700016
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 695070346 *Terms of Use

Device Description: This is 1 set with following device AGNES-S: 1EA GA-B: 10EA, GA-C: 10EA, GA-E: 10EA, GA-F1A: 10EA, GA-F1B: 10EA, GA-I: 10EA GA-IL: 10EA, GA-S: 10EA, GA-SL: 10EA, GA-W3A: 10EA, GA-F3A: 10EA, GA-W3B: 10EA AG-CN18G: 10EA, AG-CN19G: 10EA, AG-CN20G: 10EA, AG-CN21G: 10EA, AG-CN23G: 10EA

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):	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?
66285	Intradermal radio-frequency ablation system	An assembly of devices designed to apply radio-frequency (RF) energy to heat the dermal layer of the skin (e.g., the sebaceous glands) [invasive] for ablation (e.g., thermolysis) during an aesthetic procedure (e.g., acne treatment). It primarily consists of an electrically-powered control unit intended to produce and regulate the RF energy, and a connected monopolar RF applicator (probe) to deliver the RF energy to the skin; it may in addition include a bipolar (noninvasive) RF applicator.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GEI	Electrosurgical, Cutting & Coagulation & Accessories
KCW	Epilator, High Frequency, Needle-Type

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K203013	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 0 and 40 Degrees Celsius
Storage Environment Humidity: between 0 and 80 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 7b5af923-1347-4f6e-8892-861dbd99a2e5
Public Version Date: July 24, 2023
Public Version Number: 1
DI Record Publish Date: July 14, 2023