Sparrow Ascent Earpiece, Left

Primary DI
00860005396962
Brand
Sparrow Ascent Earpiece, Left
Company
Spark Biomedical Inc.
Model
210
Device description
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.
Published
2023-09-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
PZRPercutaneous Nerve Stimulator For Opioid Withdrawal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PZRPercutaneous Nerve Stimulator For Opioid WithdrawalNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K230796000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K230796000Sparrow AscentSpark Biomedical, Inc.2023-06-20PZR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850052017064PackageGS128In Commercial Distribution
00860005396993PackageGS17In Commercial Distribution
00860005396962PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850052017064008500520170648500520170640850052017064
00860005396993008600053969938600053969930860005396993
00860005396962008600053969628600053969620860005396962

GMDN Terms#

Term, Definition table
TermDefinition
Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulatorA 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature40 Degrees Fahrenheit100 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
074715155
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850052017552Sparrow Ascent313313-k2026-02-02
00850052017019Sparrow Ascent Earpiece, Right2112023-09-07
00850052017033Sparrow Ascent Replacement Kit11-110-K2023-09-07
00850052017040Sparrow Ascent Cable810-P2023-09-07
00850052017071Sparrow Ascent 28 Piece Kit (B2B)11-320-K-282023-09-07
00850052017088Sparrow Ascent 28 Piece Kit (B2C)11-310-K-282023-09-07
00860005396948Sparrow Ascent Kit (B2C)11-310-K2023-09-07
00860005396955Sparrow Ascent Patient Controller1102023-09-07
00860005396979Sparrow Ascent Cable8102023-09-07
00860005396986Sparrow Ascent Kit (B2B)11-320-K2023-09-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08908006064311Morph DeviceNEUROSTIMULATION MEDTECH PRIVATE LIMITEDPZR2026-05-22
08908006064083Drug Relief v1NEUROSTIMULATION MEDTECH PRIVATE LIMITEDPZR2026-03-16
08908006064205OpiEaseNEUROSTIMULATION MEDTECH PRIVATE LIMITEDPZR2026-03-16
00850052017552Sparrow AscentSpark Biomedical Inc.PZR2026-02-02
08908006064113Morph DeviceNEUROSTIMULATION MEDTECH PRIVATE LIMITEDPZR2024-07-20
08908006064120S.T. GenesisNEUROSTIMULATION MEDTECH PRIVATE LIMITEDPZR2024-07-20
08908006064106OpiReliefNEUROSTIMULATION MEDTECH PRIVATE LIMITEDPZR2024-07-19
00850052017019Sparrow Ascent Earpiece, RightSpark Biomedical Inc.PZR2023-09-07
00850052017033Sparrow Ascent Replacement KitSpark Biomedical Inc.PZR2023-09-07
00850052017040Sparrow Ascent CableSpark Biomedical Inc.PZR2023-09-07
00850052017071Sparrow Ascent 28 Piece Kit (B2B)Spark Biomedical Inc.PZR2023-09-07
00850052017088Sparrow Ascent 28 Piece Kit (B2C)Spark Biomedical Inc.PZR2023-09-07
00860005396948Sparrow Ascent Kit (B2C)Spark Biomedical Inc.PZR2023-09-07
00860005396955Sparrow Ascent Patient ControllerSpark Biomedical Inc.PZR2023-09-07
00860005396979Sparrow Ascent CableSpark Biomedical Inc.PZR2023-09-07
00860005396986Sparrow Ascent Kit (B2B)Spark Biomedical Inc.PZR2023-09-07
B960NSS200NSS-2 BridgeNeuraxis, Inc.PZR2021-02-12
B960NSS2001NSS-2 BridgeInnovative Health Solutions, IncPZR2021-02-12
B327NSS200NSS-2KEY ELECTRONICS, INC.PZR2018-03-30