AccessGUDID - DEVICE: PainShield 3.0 Actuator (07290103421144)

GUDID

Device Identifier (DI) Information

Brand Name: PainShield 3.0 Actuator
Version or Model: 3.0
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 10-600-0002
Company Name: NANOVIBRONIX INC.

Primary DI Number: 07290103421144
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080326793 *Terms of Use

Device Description: PainShield actuator is part of the PainShield MD System.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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?
65731	Physical therapy ultrasound system applicator, adhesive	A component of a physical therapy ultrasound system that includes a transducer designed to convert electric voltages into ultrasound energy [e.g., frequencies greater than 20 kilohertz (kHz)] and directs this energy into body tissues; it is held in place on the skin by an adhesive patch typically for several hours. The localized thermal and nonthermal effects generated by the ultrasonic energy is associated with increased blood flow in the treated area and is intended to accelerate tissue repair and/or reduce pain. Disposable adhesive patches are included with the device. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PFW	Stationary Ultrasonic Diathermy Device For Use In 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
Storage Environment Humidity: between 10 and 80 Percent (%) Relative Humidity
Storage Environment Temperature: between 5 and 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e7155837-bbf2-4e0b-8c61-a261c4965d17
Public Version Date: July 24, 2023
Public Version Number: 1
DI Record Publish Date: July 16, 2023

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 914-233-3004
Email: info@nanovibronix.com

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES