AccessGUDID - DEVICE: Sparrow Ascent 28 Piece Kit (B2B) (00850052017071)

GUDID

Device Identifier (DI) Information

Brand Name: Sparrow Ascent 28 Piece Kit (B2B)
Version or Model: 11-320-K-28
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Spark Biomedical Inc.

Primary DI Number: 00850052017071
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 074715155 *Terms of Use

Device Description: A starter pack with all the components for acute withdrawal management using Transcutaneous Auricular Neurostimulation (tAN®). This pack includes the Sparrow Ascent Kit and three Sparrow Ascent Left Earpiece Kits. (1) GTIN: 00860005396986 (Base kit containing the Patient Controller, Cable, Belt Clip, QSG, Batteries, seven Alcohol Wipes, and seven Left Earpieces) (3) GTIN: 00860005396993

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):	Yes
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?
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: 7a129f47-b1d9-4bed-89c3-eb1c4678e133
Public Version Date: October 18, 2023
Public Version Number: 2
DI Record Publish Date: September 07, 2023