FDA UDI
Not in Commercial Distribution
🇺🇸 United States
microTargeting™ STar™ Insertion Tube
DI: 10873263001193
·
Model: FC8009-00119
·
FHC, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
5
Basic Information
- Brand Name
- microTargeting™ STar™ Insertion Tube
- Primary DI
- 10873263001193
- Version / Model
- FC8009-00119
- Catalog Number
- FC8009
- Company Name
- FHC, INC.
- Labeler DUNS
- 108179458
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2016-08-22
- Public Version
- 5
- Public Version Date
- 2023-01-10
- Public Version Status
- Update
- Public Device Record Key
- 9f58dfb8-8043-4ba1-aee6-01f43a516216
- Distribution End Date
- 2023-01-10
Device Description
microTargeting STar Drive Array Electrode Insertion Tube Set with Stylet, 5x, Sterile, for use with a Stereotactic Frame. Each Kit Contains: (1) IT(AR16) Insertion Tube Guide - 1.83mm OD, 0.96mm ID (does not enter brain) (1) IT(AR17) Insertion Tube w/ Stylet - 241.5mm tube length, 0.90mm tube OD, 0.60mm tube ID
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
- 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
- Yes
- Sterilization Methods
- ["Ethylene Oxide", "Moist Heat or Steam Sterilization"]
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| 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 | 10873263001193 | GS1 | ||||
| Unit of Use | 00873263001196 | GS1 |
Customer Contacts
- Phone
- +1(800)326-2905
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K092562 | 000 |
Storage Conditions
- Type
- Handling Environment Humidity
- Temperature Range
- 0 – 95 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 40 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 0 – 95 Percent (%) Relative Humidity