AccessGUDID - DEVICE: RICA Surgical Products (00810147254668)

GUDID

Device Identifier (DI) Information

Brand Name: RICA Surgical Products
Version or Model: R648L-W
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: INTERNATIONAL SURGICAL PRODUCTS INC

Primary DI Number: 00810147254668
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 197053028 *Terms of Use

Device Description: LARGE COOLING ROLLER W/WHITE HANDLE

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
LYG	Massager, Therapeutic, Manual

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: a9b5bbfe-7452-4565-8495-710d16819ad8
Public Version Date: December 27, 2024
Public Version Number: 1
DI Record Publish Date: December 19, 2024