AccessGUDID - DEVICE: StimQ Freedom-4A Trial Kit Channel B US w/ Receiver (00818225020709)

GUDID

Device Identifier (DI) Information

Brand Name: StimQ Freedom-4A Trial Kit Channel B US w/ Receiver
Version or Model: FR4A-TRL-B0
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: STIMWAVE TECHNOLOGIES INCORPORATED

Primary DI Number: 00818225020709
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 StimQ Freedom-4A Trial Kit Channel B US w/ Receiver

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: 10355a66-f515-45e7-97c8-ebc664cd4bda
Public Version Date: October 07, 2019
Public Version Number: 4
DI Record Publish Date: February 05, 2018