FDA UDI
In Commercial Distribution
🇺🇸 United States
Natus®
DI: 00382830055550
·
Model: NT955113
·
NATUS MEDICAL INCORPORATED
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Natus®
- Primary DI
- 00382830055550
- Version / Model
- NT955113
- Catalog Number
- NT955113
- Company Name
- NATUS MEDICAL INCORPORATED
- Labeler DUNS
- 081325959
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-04-03
- Public Version
- 1
- Public Version Date
- 2020-04-13
- Public Version Status
- New
- Public Device Record Key
- 4e5c6c08-530a-4b57-91a6-31d21e630b38
Device Description
BURR HOLE RESERVOIR AND SILICONE CAP (Stainless Steel - Ø 6.4 mm - Depth 0.8 mm)
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
- Yes
- MRI Safety
- MR Conditional
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- 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 |
|---|---|---|---|---|
| 61375 | Cranial port/reservoir | A sterile, implantable chamber intended to be connected to an intracerebral catheter for infusion/injection of materials (e.g., chemotherapeutic agents, radioisotopes) into the brain (e.g., cerebral ventricles, cystic tumours, tumour cavities); it may also be used for drainage of cerebrospinal fluid (CSF) from the ventricles and as part of a ventriculo-peritoneal/atrial shunt system. The device is implanted subcutaneously and materials infused/injected with a needle via hypodermic puncture flow into the target site through the connected catheter. It is typically a bulb-shaped device made of plastic material (e.g., polypropylene, silicone). This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00382830055550 | GS1 | ||||
| Previous | 10381780034346 | GS1 |
Customer Contacts
- Phone
- 1-800-356-0007
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K152897 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 0.8mm Depth x 6.4mm Diam. |