FDA UDI
In Commercial Distribution
🇺🇸 United States
microTargeting™ STar™ Drive Insertion Tube Set
DI: 00873263002179
·
Model: 70-IT-AR-00217
·
FHC, INC.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- microTargeting™ STar™ Drive Insertion Tube Set
- Primary DI
- 00873263002179
- Version / Model
- 70-IT-AR-00217
- Catalog Number
- 70-IT-AR
- Company Name
- FHC, INC.
- Labeler DUNS
- 108179458
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-17
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 5a4b778d-d8a8-495a-8aaa-eabf4a274ab7
Device Description
STar(TM) Drive Array Electrode Insertion Tube Set for use with stereotactic frames, non-sterile Contains: 6 - IT(AR16) Guide Tube (does not enter brain) 6 - IT(AR17) Insertion Tube with Stylet - 241.5mm length, 0.90mm od, 0.60mm id 1 - IT(AR3), DBS Lead Insertion Tube with Stylet - 239.85mm length, 1.83mm od, 1.60mm id 2 - Insertion Tube Extractors
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
- MR Unsafe
- Direct Marking Exempt
- Yes
- 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
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HAO | INSTRUMENT, SURGICAL, NON-POWERED | Neurology | 882.4535 | 1 |
| HAW | Neurological stereotaxic Instrument | Neurology | 882.4560 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61964 | Intracerebral cannula, implantable | A sterile, implantable tube intended to be surgically placed in a specific area of the brain (e.g., basal ganglia) to position a deep brain electrical stimulation lead/electrode, using a stereotactic surgery system, and to function as a guide for subsequent and regular placement and/or removal of the lead/electrode. It is made of synthetic polymer materials (e.g., polyurethane) and may include a stylet/trocar blade. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00873263002179 | GS1 |
Customer Contacts
- Phone
- +1(800)326-2905
- [email protected]
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- High: 95 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 40 Degrees Celsius