FDA UDI
In Commercial Distribution
🇺🇸 United States
Innervision
DI: 00613994908483
·
Model: 2120-125
·
MEDTRONIC PS MEDICAL, INC.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Innervision
- Primary DI
- 00613994908483
- Version / Model
- 2120-125
- Company Name
- MEDTRONIC PS MEDICAL, INC.
- Labeler DUNS
- 089055867
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-07-21
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 6978b566-d3a1-41de-af44-2f3658e5aafb
Device Description
KIT 2120-125 INNER/ENDO SHUNT PLCMT REG
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| GWG | ENDOSCOPE, NEUROLOGICAL | Neurology | 882.1480 | 2 |
| HCA | CATHETER, VENTRICULAR | Neurology | 882.4100 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61491 | Neuroscopic shunt placement kit | A collection of sterile devices intended to be used to implant an intracerebral ventricular catheter in a brain ventricle to function as a component of a ventriculo-peritoneal/atrial shunt for diversion of excessive cerebrospinal fluid (CSF) from the brain. The kit includes the catheter and a single-use rigid neuroscope intended for visual placement of the catheter; additional devices dedicated to catheter introduction/function (e.g., stylet) may be included. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00613994908483 | GS1 |
Customer Contacts
- Phone
- +1(800)633-8766
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K940096 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Angle | 0.0 | degree | |
| Outer Diameter | 1.1 | Millimeter | |
| Length | 15.5 | Centimeter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry
- Type
- Special Storage Condition, Specify
- Special Conditions
- Fragile