FDA UDI
In Commercial Distribution
🇺🇸 United States
ShuntPen Cannula
DI: B0672120C1
·
Model: 2120C
·
CLARUS MEDICAL, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
5
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Basic Information
- Brand Name
- ShuntPen Cannula
- Primary DI
- B0672120C1
- Version / Model
- 2120C
- Catalog Number
- 2120C
- Company Name
- CLARUS MEDICAL, LLC
- Labeler DUNS
- 010316284
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2016-09-22
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 6a3a5f09-0a83-4ec6-9ef9-00ff2421fe99
Device Description
ShuntPen Cannula, to be used with Clarus 3000N Flexible Fiberoptic Endoscope.
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
- Yes
- 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 |
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 | B0672120C1 | HIBCC | ||||
| Unit of Use | B0672120C0 | HIBCC |
Customer Contacts
- Phone
- 763-525-8400
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K942249 | 000 |