AccessGUDID - DEVICE: HotRock (00860000412711)

GUDID

Device Identifier (DI) Information

Brand Name: HotRock
Version or Model: HR-001
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MEDROCK, INC

Primary DI Number: 00860000412711
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 034446946 *Terms of Use

Device Description: HotRock is a self-heated foam roller used to relieve minor ache and pains. It is basically a heating pad built into a foam roller.

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):	No
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?
34009	External manual massager, clinical	A manual (non-powered) device designed to apply external massage to a patient, by the patient, staff, or a therapist in a hospital, institution, or therapeutic treatment situation. It is intended to stimulate/massage body muscles to provide a therapeutic effect. It is typically designed to be held in the hands and is available in a variety of configurations and materials, e.g., plastic, wood, ceramics. It is available in a variety of sizes and shapes and may be a one-piece device or have interchangeable massaging components (e.g., roller heads or pads), and have a variety of massage surfaces (e.g., points, ribs, smooth). This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ISA	Massager, Therapeutic, Electric

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
Storage Environment Temperature: between -20 and 120 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: dd89019b-5a0b-440e-b2e0-e6c4d35d02c7
Public Version Date: August 20, 2020
Public Version Number: 2
DI Record Publish Date: June 16, 2020