AccessGUDID - DEVICE: Performa (00885914077436)

GUDID

Device Identifier (DI) Information

Brand Name: Performa
Version or Model: 081710748
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 081710748
Company Name: Performance Health Supply, LLC

Primary DI Number: 00885914077436
Issuing Agency: GS1
Commercial Distribution End Date: December 07, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 966806150 *Terms of Use

Device Description: Performa Sonishield Antimicrobial Ultrasound Gel 8.5 oz

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?
15321	Skin topical coupling gel	A medium designed to be applied to a patient's unbroken skin surface (excludes the eye surface) to provide a coupling between an analytical or therapeutic device (e.g., ultrasound transducer, optical glucose monitoring system, transcutaneous electrical stimulator) and the patient, allowing for the emission and reception of energy/signals (e.g., electrical current, light) that pass through the skin during an examination or treatment. It is in the form of a fluid-like gel that may also assist in moving the parent device smoothly over the skin. It may be used by a healthcare professional in a clinical setting and layperson in the home. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MUI	Media,Coupling,Ultrasound

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K151070	000

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
Total Volume: 8.5 Fluid Ounce

Device Record Status

Public Device Record Key: e50d9fe1-3fee-4b43-a3c6-5a7c775e4917
Public Version Date: December 08, 2023
Public Version Number: 7
DI Record Publish Date: October 13, 2017