AccessGUDID - DEVICE: CRYO T-SHOCK 4.0 (08056590170441)

GUDID

Device Identifier (DI) Information

Brand Name: CRYO T-SHOCK 4.0
Version or Model: CRYO T-SHOCK 4.0
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ELETTRONICA PAGANI SRL

Primary DI Number: 08056590170441
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 430315948 *Terms of Use

Device Description: Cold and hot generator for skin cooling and heating in minor pain and skin imperfections.

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?
61186	Multi-modality physical therapy system, professional-use	An assembly of electrically-powered devices designed for professional use to apply multiple different energies (e.g., light-energy, ultrasound, radio-frequency electrical stimulation, electrotherapy) either alone or in sequence, but not simultaneously, to noninvasively treat/prevent a variety of soft-tissue, neuromuscular, and musculoskeletal injuries/disorders (e.g., joint pain/inflammation, stiffness, soft tissue injuries, muscle atrophy); it may in addition be used for aesthetic skin/body contouring (e.g., minimize cellulite, loose or wrinkled skin). It consists of a multi-modality control unit/generator, and dedicated applicators for the transcutaneous delivery of energy.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IME	Pack, Hot Or Cold, Reusable

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: 9ceee173-498a-4215-b6ab-283f6fa124ad
Public Version Date: April 18, 2025
Public Version Number: 2
DI Record Publish Date: April 24, 2022