FDA UDI
In Commercial Distribution
🇺🇸 United States
SMARTFrame Expanded Accessory Kit, 7 Fr
DI: 00850047354075
·
Model: NGS-EAK-01-11-7
·
Clearpoint Neuro, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- SMARTFrame Expanded Accessory Kit, 7 Fr
- Primary DI
- 00850047354075
- Version / Model
- NGS-EAK-01-11-7
- Catalog Number
- NGS-EAK-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
- 2024-05-16
- Public Version
- 1
- Public Version Date
- 2024-05-24
- Public Version Status
- New
- Public Device Record Key
- 5f2b7100-a96f-4da4-b706-e2a9d4c65dd1
Device Description
SMARTFrame Expanded Accessory Kit, 7 Fr
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
- Yes
- 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 | 00850047354075 | GS1 |
Customer Contacts
- Phone
- 949-900-6833
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K200079 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 7 French |