AccessGUDID - DEVICE: Disposable Applicator Cover (20868924000018)

GUDID

Device Identifier (DI) Information

Brand Name: Disposable Applicator Cover
Version or Model: PVTC30
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Regenesis Biomedical, Inc.

Primary DI Number: 20868924000018
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 30
Labeler D-U-N-S® Number*: 018207519 *Terms of Use

Device Description: Disposable Applicator Covers are single-use-only and are intended to help protect the Treatment Applicator from biological contamination. The cover is non-sterile and manufactured of polyethylene terephthalate (polyester) film and contains a Radio Frequency Identification Device (RFID) tag, which guards against reuse of used Disposable Applicator Covers.

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:	Yes
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?
62236	Electromagnetic stimulation system application pad	A non-sterile pad intended to be placed on the skin of a patient, or on the parent device, to provide a contact surface for an electromagnetic stimulation applicator, and a barrier to cross-contamination between the applicator and the patient, during treatment. It is typically made of polyethylene terephthalate (polyester) film and may contain a radio-frequency identification (RFID) tag which helps prevent reuse of the pad. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ILX	Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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: 2fb830a0-e266-4999-a113-48a2a984cf5b
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 16, 2016