FDA UDI
In Commercial Distribution
🇺🇸 United States
N/A
DI: 20643169471522
·
Model: 46442
·
MEDTRONIC PS MEDICAL, INC.
Product Codes
3
GMDN Terms
1
Identifiers
2
Pkg Device Count
5
Basic Information
- Brand Name
- N/A
- Primary DI
- 20643169471522
- Version / Model
- 46442
- Company Name
- MEDTRONIC PS MEDICAL, INC.
- Labeler DUNS
- 089055867
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2015-07-15
- Public Version
- 4
- Public Version Date
- 2021-02-09
- Public Version Status
- Update
- Public Device Record Key
- ed82e24e-1545-4e87-8094-937c38c885a8
Device Description
KIT 46442 EDM LUMBAR DRN CLS TIP 5PK
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 |
|---|---|---|---|---|
| GWM | DEVICE, MONITORING, INTRACRANIAL PRESSURE | Neurology | 882.1620 | 2 |
| JXG | Shunt, central nervous system and components | Neurology | 882.5550 | 2 |
| GWN | NYSTAGMOGRAPH | Neurology | 882.1460 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61797 | Lumbar cerebrospinal fluid drainage catheterization kit | A collection of sterile devices intended for short-term percutaneous access to the subarachnoid (intrathecal) or epidural space of the lumbar spinal column to drain cerebrospinal fluid (CSF), and/or other fluids of similar physical characteristics, as a means of reducing CSF volume and intracranial pressure (ICP). It includes a spinal infusion/drainage catheter and devices intended for catheter insertion (e.g. Tuohy needle, suture, guidewire) and CSF collection (e.g., drip chamber, drainage bag, tubing set, filter). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 20643169471522 | GS1 | ||||
| Unit of Use | 00643169471528 | GS1 |
Customer Contacts
- Phone
- +1(800)633-8766
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K984053 | 000 |