FDA UDI
In Commercial Distribution
🇺🇸 United States
microTargeting™ Insertion Tubes 1x
DI: 00873263004777
·
Model: 66-IT(AR22)-00477
·
FHC, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- microTargeting™ Insertion Tubes 1x
- Primary DI
- 00873263004777
- Version / Model
- 66-IT(AR22)-00477
- Catalog Number
- 66-IT(AR22)
- 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
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- f9dc0486-fe0a-48ad-8dd2-082f69a02b8f
Device Description
microTargeting Insertion Tubes, 1x, nonsterile
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
- ["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 | 00873263004777 | GS1 |
Customer Contacts
- Phone
- +1(800)326-2905
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K011775 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 126.4 | Millimeter | |
| Lumen/Inner Diameter | 0.96 | Millimeter | |
| Outer Diameter | 1.83 | Millimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 40 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 0 – 95 Percent (%) Relative Humidity
- Type
- Handling Environment Humidity
- Temperature Range
- 0 – 95 Percent (%) Relative Humidity