FDA UDI
In Commercial Distribution
🇺🇸 United States
NA
DI: 00643169579385
·
Model: 22101 A
·
MEDTRONIC POWERED SURGICAL SOLUTIONS
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- NA
- Primary DI
- 00643169579385
- Version / Model
- 22101 A
- Company Name
- MEDTRONIC POWERED SURGICAL SOLUTIONS
- Labeler DUNS
- 098308849
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-06-24
- Public Version
- 4
- Public Version Date
- 2025-09-11
- Public Version Status
- Update
- Public Device Record Key
- 3b49df8b-22af-4a67-9daf-1b7199d643d0
Device Description
RES 22101 A NEO FLAT DOME W/ 3.0CM VCATH
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 |
|---|---|---|---|---|
| LKG | Port & catheter, implanted, subcutaneous, intraventricular | 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 | 00643169579385 | GS1 |
Customer Contacts
- Phone
- +1(800)633-8766
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K874498 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 3.0 | Centimeter |