FDA UDI
In Commercial Distribution
🇺🇸 United States
Sophysa
DI: 03760124131963
·
Model: SAK-SI
·
SOPHYSA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Sophysa
- Primary DI
- 03760124131963
- Version / Model
- SAK-SI
- Company Name
- SOPHYSA
- Labeler DUNS
- 262951353
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-10-16
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 1e1e916b-ea1a-4eb5-b712-604506981481
Device Description
SOPHY SETTING INSTRUMENT
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- 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
- 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 |
|---|---|---|---|---|
| JXG | Shunt, central nervous system and components | Neurology | 882.5550 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44856 | Cerebrospinal fluid shunt valve programmer | A device intended to noninvasively modify the operating pressure of a programmable, non-active, implanted hydrocephalic valve that will be part of a hydrocephalic shunt system. It is used in neurosurgery for intra- and postoperative treatment of hydrocephalus when shunting cerebrospinal fluid (CSF) from the ventricles of the brain. It typically includes electronic circuits, a control panel, a programming information display, and transmitter/identification devices (e.g., smart cards). When externally placed on the location of the implanted valve, it is actuated to supply coded magnetic signals to affect mechanical changes to the pressure characteristics of the proprietary implanted valve. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03760124131963 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K013488 | 000 |