FDA UDI
In Commercial Distribution
🇺🇸 United States
StimQ Freedom-4A Receiver Kit Channel A US w/ Receiver
DI: 00818225020730
·
Model: FR4A-RCV-A0
·
STIMWAVE TECHNOLOGIES INCORPORATED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- StimQ Freedom-4A Receiver Kit Channel A US w/ Receiver
- Primary DI
- 00818225020730
- Version / Model
- FR4A-RCV-A0
- Company Name
- STIMWAVE TECHNOLOGIES INCORPORATED
- Labeler DUNS
- 078294927
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-02-05
- Public Version
- 4
- Public Version Date
- 2019-10-07
- Public Version Status
- Update
- Public Device Record Key
- 21246bdc-36c4-4194-b3ff-ae5e6cf4df0d
Device Description
StimQ Peripheral Nerve Stimulator System StimQ Freedom-4A Receiver Kit Channel A US w/ Receiver
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- Yes
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Ethylene Oxide
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GZF | Stimulator, Peripheral Nerve, Implanted (Pain Relief) | Neurology | 882.5870 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38474 | Analgesic implantable peripheral nerve electrical stimulation system | An assembly of devices designed to stimulate electrically a peripheral nerve in a patient to relieve severe intractable pain. It typically consists of an implanted receiver with electrodes that are placed around a peripheral nerve and an external transmitter for transmitting the stimulating pulses across the patient's skin to the implanted receiver. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00818225020730 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K171366 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Weight | 0.25 | Gram | |
| Length | 45 | Centimeter | |
| Outer Diameter | 1.35 | Millimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -18 – 60 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 140 Degrees Fahrenheit