AccessGUDID - DEVICE: Sparrow Ascent Cable (00860005396979)

GUDID

Device Identifier (DI) Information

Brand Name: Sparrow Ascent Cable
Version or Model: 810
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Spark Biomedical Inc.

Primary DI Number: 00860005396979
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 074715155 *Terms of Use

Device Description: The Sparrow Ascent Cable is 37 inches long and connects the Patient Controller to the Earpiece. The Cable length is designed to allow the user to carry the Patient Controller in a pocket or worn in the Belt Clip(model 610) without constricting mobility. A built-in retention clip allows the user to clip the Cable to their clothing to relieve cable strain. This is a subcomponent and is not transacted. See 810-P.

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?
63321	Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator	A body-worn, electronic device intended to provide percutaneous electrical nerve field stimulation (PENFS) applied close to cranial/peripheral nerves around the external ear to achieve remote symptom relief mediated by central nervous system (CNS) pathways and structures [e.g., amygdala, spinal cord neurons]; depending on the treatment protocol and device settings it may be used for opioid withdrawal symptoms (e.g., bone/joint aches, tremor, anxiety), or irritable bowel syndrome [IBS]-associated functional abdominal pain (FAP). It consists of an electrical pulse generator with minimally-invasive electrodes, and accessories (e.g., adhesives, transilluminator). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PZR	Percutaneous Nerve Stimulator For Opioid Withdrawal

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K230796	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f7b5b453-35fc-4069-b2b1-86e922bb179b
Public Version Date: October 18, 2023
Public Version Number: 2
DI Record Publish Date: September 07, 2023