FDA UDI
In Commercial Distribution
🇺🇸 United States
Sparrow Ascent Earpiece, Right
DI: 00850052017019
·
Model: 211
·
Spark Biomedical Inc.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Sparrow Ascent Earpiece, Right
- Primary DI
- 00850052017019
- Version / Model
- 211
- Company Name
- Spark Biomedical Inc.
- Labeler DUNS
- 074715155
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-09-07
- Public Version
- 2
- Public Version Date
- 2023-10-18
- Public Version Status
- Update
- Public Device Record Key
- b8c0b73b-c4ba-4708-ba4c-fb6871f63048
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.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- Yes
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| PZR | Percutaneous Nerve Stimulator For Opioid Withdrawal | Neurology | 882.5896 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850052017019 | GS1 | ||||
| Package | 00850052017002 | GS1 | Box | 7 | In Commercial Distribution | |
| Package | 00850052017057 | GS1 | Box | 28 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K230796 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 40 – 100 Degrees Fahrenheit