FDA UDI
In Commercial Distribution
🇺🇸 United States
Navigated Brain Biopsy Cannula
DI: 00815212020346
·
Model: MB3005
·
Izi Medical Products, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Navigated Brain Biopsy Cannula
- Primary DI
- 00815212020346
- Version / Model
- MB3005
- Company Name
- Izi Medical Products, LLC
- Labeler DUNS
- 933506164
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-06-02
- Public Version
- 1
- Public Version Date
- 2020-06-10
- Public Version Status
- New
- Public Device Record Key
- 6b2beac3-6b66-44ac-a6af-31d5d1d257a7
Device Description
Navigated Brain Biopsy Cannula - Compatible Medtronics
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- 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 |
|---|---|---|---|---|
| 38563 | Brain biopsy procedure kit | A packaged collection of sterile equipment that includes a disposable brain biopsy needle and other supplies used to perform a stereotaxic sampling of brain tissue. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00815212020346 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K143241 | 000 |