Sparrow Ascent Earpiece, Left

GUDID 00860005396962

The Earpiece is a disposable component of the Sparrow Ascent and is designed to stay adhered to the skin of the left or right ear for up to 24 hours of electrical connectivity. The Inner Electrode interfaces with the cymba concha and the Outer Electrode interfaces with the trigeminal nerve. The Back Electrode is the return Electrode for both the Inner and Outer Electrodes.

Spark Biomedical Inc.

Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator
Primary Device ID00860005396962
NIH Device Record Keya3f4b03b-1fc2-4b37-8f4c-d20a39b1b829
Commercial Distribution StatusIn Commercial Distribution
Brand NameSparrow Ascent Earpiece, Left
Version Model Number210
Company DUNS074715155
Company NameSpark Biomedical Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 100 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 100 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100850052017064 [Package]
Package: Box [28 Units]
In Commercial Distribution
GS100860005396962 [Primary]
GS100860005396993 [Package]
Package: Box [7 Units]
In Commercial Distribution

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 Kit2023-09-15 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, Left2023-09-15The Earpiece is a disposable component of the Sparrow Ascent and is designed to stay adhered to the skin of the left or right ear for up to 24 hours of electrical connectivity. The Inner Electrode interfaces with the cymba concha and the Outer Electrode interfaces with the trigeminal nerve. The Back Electrode is the return Electrode for both the Inner and Outer Electrodes.
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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