FDA UDI
In Commercial Distribution
🇺🇸 United States
ClearPoint PURSUIT
DI: 00850359007683
·
Model: MCA-53-250
·
Clearpoint Neuro, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ClearPoint PURSUIT
- Primary DI
- 00850359007683
- Version / Model
- MCA-53-250
- Catalog Number
- MCA-53-250
- Company Name
- Clearpoint Neuro, Inc.
- Labeler DUNS
- 119078557
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-01-22
- Public Version
- 4
- Public Version Date
- 2023-11-29
- Public Version Status
- Update
- Public Device Record Key
- 480824ef-81c8-431d-882e-d525bbda7b7f
Device Description
MR Compatible Aspiration Kit, 5.3 mm OD x 250 mm Length
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
- MR Safe
- 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 |
|---|---|---|---|---|
| 47994 | Endoscopic cyst-aspiration set | A collection of sterile devices designed to stabilize and aspirate a cyst or other internal anatomical structure under direct endoscopic vision during a surgical procedure, typically enabling aspiration of fluid without leakage into the surrounding anatomy (e.g., the peritoneal cavity). It typically consists of a long, slender, sharply-pointed, metal needle (e.g., stainless steel) within an aspiration tube [e.g., stainless steel or polycarbonate (PC)] that is applied to the lesion with suction; it may include adaptors and tubing to connect to the source of suction. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850359007683 | GS1 |
Customer Contacts
- Phone
- 9499006833
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K181731 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 5.3 | Millimeter |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 40 – 90 Degrees Fahrenheit