FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Phoenix Neuro
DI: 03760124136999
·
Model: RA07
·
SOPHYSA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Phoenix Neuro
- Primary DI
- 03760124136999
- Version / Model
- RA07
- Company Name
- SOPHYSA
- Labeler DUNS
- 262951353
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-10-16
- Public Version
- 4
- Public Version Date
- 2023-05-18
- Public Version Status
- Update
- Public Device Record Key
- 74ce09be-9a1a-49d5-8343-8a2c02a8952a
- Distribution End Date
- 2023-05-16
Device Description
Perf. Catheter Reservoir, Large dome, AB, 7 cm
Device Characteristics
- Single Use
- Yes
- 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 Safe
- 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
- Yes
- 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 |
|---|---|---|---|---|
| 65412 | Cerebrospinal fluid shunt port/reservoir | An implantable component of a lumboperitoneal, ventriculoperitoneal or ventriculoatrial shunt designed to be connected to a lumbar, ventricular and/or peritoneal catheter (not included) to permit hypodermic infusion/injection of materials (e.g., chemotherapeutic agents, radioisotopes) into the central nervous system via the subarachnoid lumbar or cerebral space, in the management of raised cerebrospinal fluid (CSF) pressure (e.g., caused by hydrocephalus); it may also be used for drainage of CSF. It consists of a plastic puncturable dome with catheter connections; it does not include a valve. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03760124136999 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K021644 | 000 |