FDA UDI
Not in Commercial Distribution
🇺🇸 United States
microTargeting™ Insertion Tube
DI: 10873263001124
·
Model: FC1018-00112
·
FHC, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
5
Basic Information
- Brand Name
- microTargeting™ Insertion Tube
- Primary DI
- 10873263001124
- Version / Model
- FC1018-00112
- Catalog Number
- FC1018
- 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
- 52e9c4f5-e69c-43bf-bf11-92f24f2fa594
- Distribution End Date
- 2023-01-10
Device Description
microTargeting Array Electrode Insertion Tube with Stylet, Sterile, 5x for use with mT Drive Includes and one IT(AR1) and one IT(AR2). Individual Specifications: IT(AR1): Length=239.9mm, OD=0.88mm, ID=0.58mm IT(AR2): OD=1.83mm, ID=0.97mm (does not enter brain)
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
- Labeling does not contain MRI Safety Information
- 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
- ["Moist Heat or Steam Sterilization", "Ethylene Oxide"]
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 | 10873263001124 | GS1 | ||||
| Unit of Use | 00873263001127 | GS1 |
Customer Contacts
- Phone
- +1(800)326-2905
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K011775 | 000 |
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 0 – 95 Percent (%) Relative Humidity
- Type
- Handling Environment Humidity
- Temperature Range
- 0 – 95 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 40 Degrees Celsius