AccessGUDID - DEVICE: CycloTens Refill Pak (00370914013015)

GUDID

Device Identifier (DI) Information

Brand Name: CycloTens Refill Pak
Version or Model: 50054A
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: HUDSON SCIENTIFIC, LLC

Primary DI Number: 00370914013015
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080339637 *Terms of Use

Device Description: One bottle 30 ct. Cyclobenzaprine 10 mg with one set of Tens Unit Electrode pads

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:	Yes
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?
35751	Transcutaneous electrical stimulation lead	A non-sterile, insulated, electrical conducting wire intended to be used to connect a transcutaneous electrical stimulation electrode to an electrical stimulus generator (e.g., TENS system generator), or a wire having a distal end that splits and terminates as electrodes which are placed on the patient for the transmission of electrical stimulation. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K133979	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
Storage Environment Temperature: between 40 and 80 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 40fa0a53-b6b9-4b55-ad90-6af881af4c39
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: July 24, 2017