AccessGUDID - DEVICE: Tixel C (07290117524046)

GUDID

Device Identifier (DI) Information

Brand Name: Tixel C
Version or Model: MSTX0002
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: NOVOXEL LTD

Primary DI Number: 07290117524046
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 600275858 *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:	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?
62362	Thermo-mechanical skin surface treatment system	A mains electricity (AC-powered) portable assembly of devices intended to be used for skin resurfacing and rejuvenation via application of pulsed thermal and mechanical energy (i.e., it does not emit radiation such as laser or radio-frequency energy) on the skin surface for ablative and/or non-ablative treatment of various skin conditions (e.g., pigmentation, scarring, actinic keratosis, acne, wrinkles). It consists of a control/display unit, a handpiece, and a removable heat-conductive handpiece tip made of metal, typically with small pointed pins designed to make repeated fractional contact with the skin surface.	Active	false

FDA Product Code

[?]

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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K202988	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 2dc47bb0-fc0d-4b51-9555-0a521c606d54
Public Version Date: November 22, 2021
Public Version Number: 1
DI Record Publish Date: November 14, 2021

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: Yes
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES