FDA UDI
In Commercial Distribution
🇺🇸 United States
microTargeting™ Insertion Tube with Stylet
DI: 00873263008171
·
Model: 66-IT(AR31)-00817
·
FHC, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- microTargeting™ Insertion Tube with Stylet
- Primary DI
- 00873263008171
- Version / Model
- 66-IT(AR31)-00817
- Catalog Number
- 66-IT(AR31)
- Company Name
- FHC, INC.
- Labeler DUNS
- 108179458
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-09-10
- Public Version
- 1
- Public Version Date
- 2020-09-18
- Public Version Status
- New
- Public Device Record Key
- 97bcec65-6cc8-497d-9cbd-2cba2e23b9b2
Device Description
microTargeting Insertion Tube with Stylet, nonsterile, 1x
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
- Labeling does not contain MRI Safety Information
- 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 |
|---|---|---|---|---|
| 62753 | Intracerebral cannula, nonimplantable, single-use | A sterile, 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 single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00873263008171 | GS1 |
Customer Contacts
- Phone
- +1(800)326-2905
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K011775 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 1.83 | Millimeter | |
| Lumen/Inner Diameter | 1.6 | Millimeter | |
| Length | 262.9 | Millimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 40 Degrees Celsius
- Type
- Handling Environment Humidity
- Temperature Range
- 0 – 95 Percent (%) Relative Humidity