FDA UDI
In Commercial Distribution
🇺🇸 United States
STar™ Drive Insertion Tube Set
DI: 00873263002186
·
Model: 70-IT-04-00218
·
FHC, INC.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- STar™ Drive Insertion Tube Set
- Primary DI
- 00873263002186
- Version / Model
- 70-IT-04-00218
- Catalog Number
- 70-IT-04
- 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
- 3
- Public Version Date
- 2022-12-09
- Public Version Status
- Update
- Public Device Record Key
- 40014ed6-df86-4dd3-9f4f-c426e4ec803b
Device Description
STar(TM) Drive Array Electrode Insertion Tube Set for use with microTargeting(TM) Platform, non-sterile Set Contains: 6x IT(AR18) Guide Tube, 1.83mm OD (does not enter brain) 6x IT(AR19) Insertion Tube with Stylet - 186.7mm length, 0.87mm od, 0.60mm id 1x IT(AR4) DBS Lead Insertion Tube with Stylet - 188.05mm length, 1.83mm od, 1.60mm id. 2x 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 |
|---|---|---|---|---|
| 61854 | Intracerebral cannula, nonimplantable, reusable | A nonimplantable, rigid tube intended to be surgically inserted through the skull to access the brain (e.g., cerebral ventricles) for cerebrospinal fluid (CSF) drainage, infusion of materials, and/or for use as a port through which instruments, leads and/or probes can be passed to perform a variety of diagnostic, treatment, or surgical procedures. It is usually made of metal (e.g., stainless steel) and may include a stylet/trocar blade. This is a reusable device intended to be sterilized prior to use. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00873263002186 | GS1 |
Customer Contacts
- Phone
- +1(800)326-2905
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 40 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- High: 95 Percent (%) Relative Humidity