AccessGUDID - DEVICE: Dermal Cooling System (00850019947847)

GUDID

Device Identifier (DI) Information

Brand Name: Dermal Cooling System
Version or Model: M1-TIP3-10
Commercial Distribution Status: In Commercial Distribution
Catalog Number: M1-TIP3-10
Company Name: R2 Technologies, Inc.

Primary DI Number: 00850019947847
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 080023734 *Terms of Use

Device Description: Dermal Cooling System dermabrasion tip

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?
35760	Dermabrasion brush, manual	A hand-operated device with wire bristles that is used to manually plane the skin (surgical removal of the epidermis and as much of the dermis as necessary) to remove scars, tattoos, pigmented nevi, fine wrinkles, or other irregularities. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GED	BRUSH, DERMABRASION, MANUAL

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 7b8bf972-0e60-4ff1-8519-95a3e12bd27b
Public Version Date: November 19, 2024
Public Version Number: 2
DI Record Publish Date: June 09, 2023