FDA UDI
In Commercial Distribution
🇺🇸 United States
ClearPoint 7 Fr Accessory Kit
DI: 00850359007829
·
Model: NGS-AK-01-11-7
·
Clearpoint Neuro, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ClearPoint 7 Fr Accessory Kit
- Primary DI
- 00850359007829
- Version / Model
- NGS-AK-01-11-7
- Catalog Number
- NGS-AK-01-11-7
- 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
- 368b2014-3bc1-49ca-8b6e-cbbe9e80c163
- Distribution End Date
- 2035-04-30
Device Description
Clearpoint accessory kit that contains a 7 Fr Stylet and Lancet, and a peel away sheath that accepts 7 Fr devices
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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 |
|---|---|---|---|---|
| HAW | Neurological Stereotaxic Instrument | Neurology | 882.4560 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32568 | Neurological stereotactic surgery system | An assembly of devices that typically consists of a rigid frame, positioning and alignment components, workstation, and a calibrated guide mechanism for precisely positioning probes, other instruments, or implantable devices during neurosurgery. The system may include computerized functions to store diagnostic images used for image-guided surgery. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850359007829 | GS1 |
Customer Contacts
- Phone
- 9499006833
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Introducer Sheath Compatibility | 7 | French |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 40 – 90 Degrees Fahrenheit