AccessGUDID - DEVICE: StimQ SWAG Accessory Kit Lower Leg (00818225020884)

GUDID

Device Identifier (DI) Information

Brand Name: StimQ SWAG Accessory Kit Lower Leg
Version or Model: MD0339
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: STIMWAVE TECHNOLOGIES INCORPORATED

Primary DI Number: 00818225020884
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 SWAG Accessory Kit Lower Leg

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:	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?
37685	Personal device holder, reusable	A portable device designed to be worn or carried by a patient/layperson to hold a portable medical device (e.g., long-term recorder, wireless antenna, portable oxygen equipment, urine collection bag, tracheostoma protector, infusion pump) during ambulation or sleep; it is neither designed to hold an invasive tube/catheter to the skin surface (i.e., not a catheter/tube holder), nor to house and protect a device from damage (i.e., not a rigid case/housing). It is typically designed as a wearable bag, pouch, strap, belt, headband, or clothing, or as a trolley with wheels. This is a reusable device.	Active	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 [?]
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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 39a2526d-bd96-4fd9-b264-54e30dd9837a
Public Version Date: September 19, 2024
Public Version Number: 7
DI Record Publish Date: February 05, 2018