AccessGUDID - DEVICE: Tixel Handpiece (07290117524015)

GUDID

Device Identifier (DI) Information

Brand Name: Tixel Handpiece
Version or Model: THLM0002
Commercial Distribution Status: In Commercial Distribution
Catalog Number: THLM0002
Company Name: NOVOXEL LTD

Primary DI Number: 07290117524015
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 600275858 *Terms of Use

Device Description: Standard Handpiece used with TXLD0002

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?
62363	Thermo-mechanical skin surface treatment system handpiece	A mains electricity (AC-powered), hand-held device intended to apply repetitive pulsed heat and mechanical force, via an attached heat-conductive handpiece tip, to the skin surface for ablative and/or non-ablative treatment of various skin conditions (e.g., pigmentation, scarring, actinic keratosis, acne, wrinkles) during skin resurfacing and rejuvenation procedures. It is an electronic device with an activation switch designed to connect to the system’s control unit; a handpiece tip may be included. This is a reusable 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 [?]
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: b047b80b-53e9-43dc-b40c-447deb4de219
Public Version Date: November 01, 2021
Public Version Number: 1
DI Record Publish Date: October 24, 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

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