FDA UDI
In Commercial Distribution
🇺🇸 United States
SeaSilk Antenna Small 27" Length
DI: 00818225020549
·
Model: MD0812-27-SS
·
STIMWAVE TECHNOLOGIES INCORPORATED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- SeaSilk Antenna Small 27" Length
- Primary DI
- 00818225020549
- Version / Model
- MD0812-27-SS
- Company Name
- STIMWAVE TECHNOLOGIES INCORPORATED
- Labeler DUNS
- 078294927
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-10-25
- Public Version
- 2
- Public Version Date
- 2020-07-07
- Public Version Status
- Update
- Public Device Record Key
- ff24a66b-6f1d-49d2-b1ba-74e05dad5443
Device Description
SeaSilk Antenna Small 27" Length
Device Characteristics
- Single Use
- No
- 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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GZB | Stimulator, Spinal-Cord, Implanted (Pain Relief) | Neurology | 882.5880 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61393 | Multiple active implantable device programmer | An external, portable, non-dedicated, electrically-powered device intended to change, noninvasively (i.e., wirelessly), the operating parameters (programs) of multiple types of implanted electronic devices (e.g., multiple types of pulse generators); it may in addition program the external trial device used prior to the implanted one. It includes controls (e.g., graphical user interface), integrated software, and a wireless communication transmitter and receiver. It typically also provides historic and/or current information regarding the performance of the implant. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00818225020549 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K180981 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 68.58 | Centimeter | |
| Length | 27 | Inch |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -29 – 60 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 140 Degrees Fahrenheit