FDA UDI
In Commercial Distribution
🇺🇸 United States
STar™ Drive Frame Adapter
DI: 00873263006184
·
Model: 70-FA-GP-00618
·
FHC, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- STar™ Drive Frame Adapter
- Primary DI
- 00873263006184
- Version / Model
- 70-FA-GP-00618
- Catalog Number
- 70-FA-GP
- Company Name
- FHC, INC.
- Labeler DUNS
- 108179458
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-08-29
- Public Version
- 4
- Public Version Date
- 2021-06-15
- Public Version Status
- Update
- Public Device Record Key
- e3841a01-cf1a-49e0-a650-4f6e27ccf4ac
Device Description
STar™ Frame Adapter-General Purpose, 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
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- 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 |
|---|---|---|---|---|
| HAW | Neurological stereotaxic Instrument | Neurology | 882.4560 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46863 | Neurosurgical micro targeting drive | A calibrated guide mechanism used by a surgeon to manually operate a Z-axis positioner which allows extremely accurate placement of a single or multiple microelectrodes, stimulation electrodes, probes, instruments, or implantable devices, along a chosen track during neurosurgery on the brain. It is intended to be used with a neurosurgical stereotactic system. It typically consists of a metal, graduated frame along which an instrument holder traverses (e.g., approximately 50 mm) by adjustment of a graduated knob that revolves a fine pitched lead screw (e.g., one revolution of the knob will advance the drive by 1 mm). Some types can have an electrical motor attached for motorized drive. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Direct Marking | 00873263006191 | GS1 | ||||
| Primary | 00873263006184 | GS1 |
Customer Contacts
- Phone
- +1(800)326-2905
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K092562 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -34 – 57 Degrees Celsius