AccessGUDID - DEVICE: StimQ Freedom-8A Trial Kit Channel B US w/ Receiver (00818225020785)

GUDID

Device Identifier (DI) Information

Brand Name: StimQ Freedom-8A Trial Kit Channel B US w/ Receiver
Version or Model: FR8A-TRL-B0
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: STIMWAVE TECHNOLOGIES INCORPORATED

Primary DI Number: 00818225020785
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 078294927 *Terms of Use

Device Description: StimQ Peripheral Nerve Stimulator 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:	Yes
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?
38474	Analgesic implantable peripheral nerve electrical stimulation system	An assembly of devices designed to stimulate electrically a peripheral nerve in a patient to relieve severe intractable pain. It typically consists of an implanted receiver with electrodes that are placed around a peripheral nerve and an external transmitter for transmitting the stimulating pulses across the patient's skin to the implanted receiver.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
GZF	Stimulator, Peripheral Nerve, Implanted (Pain Relief)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K171366	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between -18 and 60 Degrees Celsius
Storage Environment Temperature: between 0 and 140 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Weight: 0.25 Gram
Length: 45 Centimeter
Outer Diameter: 1.35 Millimeter

Device Record Status

Public Device Record Key: 39da9751-dc40-4550-a488-5b0e468776d7
Public Version Date: October 07, 2019
Public Version Number: 4
DI Record Publish Date: February 05, 2018