FDA UDI
In Commercial Distribution
🇺🇸 United States
Sterile Revision Kit
DI: 00818225020839
·
Model: AF8A-ALL-1K
·
STIMWAVE TECHNOLOGIES INCORPORATED
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Sterile Revision Kit
- Primary DI
- 00818225020839
- Version / Model
- AF8A-ALL-1K
- 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
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 57dd3cb6-ab9c-468c-a37b-64c7c6234642
Device Description
Freedom Spinal Cord Stimulator System/StimQ Peripheral Nerve Stimulator System Sterile Revision Kit
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 |
| GZB | Stimulator, Spinal-Cord, Implanted (Pain Relief) | Neurology | 882.5880 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44063 | Neurosurgical procedure kit, non-medicated, single-use | A collection of various sterile neurosurgical instruments, dressings and the necessary materials used to perform a neurosurgical procedure. It does not contain pharmaceuticals. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00818225020839 | GS1 |
Premarket Submissions
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -18 – 60 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 140 Degrees Fahrenheit