Sparrow Ascent Replacement Kit

GUDID 00850052017033

Separate item for replacement. The Sparrow Ascent Patient Controller is a transcutaneous auricular neurostimulation (tAN) system intended to provide non-invasive, transcutaneous stimulation of the nerves on and/or around the auricle (ear). The device is indicated as an aid in the reduction of opioid withdrawal symptoms in adult patients. The Patient Controller is a battery operated, prescription device that delivers mild electrical stimulation to the nerves on and/or around the auricle (ear), which carry information to the central nervous system.

Spark Biomedical Inc.

Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator
Primary Device ID00850052017033
NIH Device Record Key47726a31-1fab-4646-be26-b1a5b18bc051
Commercial Distribution StatusIn Commercial Distribution
Brand NameSparrow Ascent Replacement Kit
Version Model Number11-110-K
Company DUNS074715155
Company NameSpark Biomedical Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100850052017033 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PZRPercutaneous Nerve Stimulator For Opioid Withdrawal

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-09-15
Device Publish Date2023-09-07

Devices Manufactured by Spark Biomedical Inc.

00850052017019 - Sparrow Ascent Earpiece, Right2023-09-15 The Earpiece is a disposable component of the Sparrow Ascent and is designed to stay adhered to the skin of the left or right ea
00850052017033 - Sparrow Ascent Replacement Kit2023-09-15Separate item for replacement. The Sparrow Ascent Patient Controller is a transcutaneous auricular neurostimulation (tAN) system intended to provide non-invasive, transcutaneous stimulation of the nerves on and/or around the auricle (ear). The device is indicated as an aid in the reduction of opioid withdrawal symptoms in adult patients. The Patient Controller is a battery operated, prescription device that delivers mild electrical stimulation to the nerves on and/or around the auricle (ear), which carry information to the central nervous system.
00850052017033 - Sparrow Ascent Replacement Kit2023-09-15 Separate item for replacement. The Sparrow Ascent Patient Controller is a transcutaneous auricular neurostimulation (tAN) system
00850052017040 - Sparrow Ascent Cable2023-09-15 The Sparrow Ascent Cable is 37 inches long and connects the Patient Controller to the Earpiece. The Cable length is designed to
00850052017071 - Sparrow Ascent 28 Piece Kit (B2B)2023-09-15 A starter pack with all the components for acute withdrawal management using Transcutaneous Auricular Neurostimulation (tAN®).
00850052017088 - Sparrow Ascent 28 Piece Kit (B2C)2023-09-15 A starter pack with all the components for acute withdrawal management using Transcutaneous Auricular Neurostimulation (tAN®).
00860005396948 - Sparrow Ascent Kit (B2C)2023-09-15 The Sparrow Ascent is a transcutaneous auricular neurostimulation (tAN) system intended to provide non-invasive, transcutaneous
00860005396955 - Sparrow Ascent Patient Controller2023-09-15 The Sparrow Ascent Patient Controller is a transcutaneous auricular neurostimulation (tAN) system intended to provide non-invasi
00860005396962 - Sparrow Ascent Earpiece, Left2023-09-15 The Earpiece is a disposable component of the Sparrow Ascent and is designed to stay adhered to the skin of the left or right ea
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