FDA UDI
In Commercial Distribution
🇺🇸 United States
NA
DI: 00673978237602
·
Model: 23069
·
MEDTRONIC PS MEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- NA
- Primary DI
- 00673978237602
- Version / Model
- 23069
- Company Name
- MEDTRONIC PS MEDICAL, INC.
- Labeler DUNS
- 089055867
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-06-30
- Public Version
- 4
- Public Version Date
- 2021-04-07
- Public Version Status
- Update
- Public Device Record Key
- 39505f31-5c64-4877-92f5-ba24ef8af5f6
Device Description
SHUNT 23069 L-P K-TUBE W/PROX TIP
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 |
|---|---|---|---|---|
| JXG | Shunt, central nervous system and components | Neurology | 882.5550 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61523 | Lumboperitoneal shunt | An implantable device intended to divert excessive cerebrospinal fluid (CSF) from the subarachnoid space of the lumbar spine to the peritoneal cavity where it can be absorbed into the body, as a treatment for raised CSF pressure (e.g., caused by hydrocephalus). It consists of fully-implantable interconnected components: a spinal catheter implanted into subarachnoid space of the lumbar spine; a mechanical shunt valve that may incorporate a puncturable port/reservoir for sampling/infusion; a peritoneal catheter implanted into the peritoneal cavity; some types incorporate a subcutaneous anchor for component connection/positioning. Disposable devices associated with implantation may be included. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00673978237602 | GS1 |
Customer Contacts
- Phone
- +1(800)633-8766
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K831396 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Lumen/Inner Diameter | 0.7 | Millimeter | |
| Length | 87.0 | Centimeter |