AccessGUDID - DEVICE: Pretika (00813859001483)

GUDID

Device Identifier (DI) Information

Brand Name: Pretika
Version or Model: ST148
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ST148
Company Name: PRETIKA CORPORATION

Primary DI Number: 00813859001483
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 848304379 *Terms of Use

Device Description: Makeup Remover Power Cleanser

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":	Yes
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
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?
64428	Ultrasonic skin surface treatment unit	An electrically-powered, hand-held device intended to apply ultrasonic vibration to the skin surface, typically the face, for treatment of acne and/or for deep cleansing. It is used in timed sessions where the vibrational energy is intended to open and unclog skin pores. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ISA	Massager, Therapeutic, Electric
GFE	Brush, Dermabrasion, Powered

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: 2bc57779-f01f-4cf1-9a1d-87faa473384e
Public Version Date: March 01, 2021
Public Version Number: 1
DI Record Publish Date: February 19, 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
10813859001480	6	00813859001483		In Commercial Distribution	Box
20813859001487	4	10813859001480		In Commercial Distribution	Master Carton

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: No
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 949-481-8818
Email: thomasnichols@pretika.com

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