Sparrow Ascent Earpiece, Right

Primary DI
00850052017019
Brand
Sparrow Ascent Earpiece, Right
Company
Spark Biomedical Inc.
Model
211
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
00850052017002PackageGS17In Commercial Distribution
00850052017057PackageGS128In Commercial Distribution
00850052017019PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850052017002008500520170028500520170020850052017002
00850052017057008500520170578500520170570850052017057
00850052017019008500520170198500520170190850052017019

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
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850052017552Sparrow Ascent313313-k2026-02-02
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
00860005396962Sparrow Ascent Earpiece, Left2102023-09-07
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
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
00860005396962Sparrow Ascent Earpiece, LeftSpark 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