FDA UDI
In Commercial Distribution
🇺🇸 United States
ClearPath
DI: 00860000321334
·
Model: AK-19-110
·
Clearmind Biomedical Inc.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- ClearPath
- Primary DI
- 00860000321334
- Version / Model
- AK-19-110
- Company Name
- Clearmind Biomedical Inc.
- Labeler DUNS
- 658832644
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-02-18
- Public Version
- 1
- Public Version Date
- 2022-02-28
- Public Version Status
- New
- Public Device Record Key
- c1d400c9-de88-4fc5-9f04-7e01ba7afae8
Device Description
ClearPath Disposable Introducer
Device Characteristics
- Single Use
- No
- 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 |
|---|---|---|---|---|
| 61440 | Intracerebral trocar blade | A sterile, hand-held, manual surgical instrument with a sharp, needle-like point intended to be used in conjunction with an intracerebral catheter (e.g., ventricular catheter) to puncture tissue and create a channel to access the brain (e.g., cerebral ventricles, cystic tumours) typically for cerebrospinal fluid (CSF) drainage or infusion of materials (e.g., chemotherapeutic agents). It is inserted within the lumen of the intracerebral catheter prior to catheter insertion; the catheter is not included. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00860000321341 | GS1 | Box | 5 | In Commercial Distribution | |
| Primary | 00860000321334 | GS1 | ||||
| Package | 00860000321358 | GS1 | Carton | 8 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K210251 | 000 |