FDA UDI
In Commercial Distribution
🇺🇸 United States
Screwdriver Bit Torx Slot
DI: G28433302
·
Model: 333-02
·
Neurovention LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Screwdriver Bit Torx Slot
- Primary DI
- G28433302
- Version / Model
- 333-02
- Company Name
- Neurovention LLC
- Labeler DUNS
- 074912476
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-06-22
- Public Version
- 1
- Public Version Date
- 2022-06-30
- Public Version Status
- New
- Public Device Record Key
- 0485c855-e831-4f6f-bf00-c8d9af8052c3
Device Description
Screwdriver Bit Torx Slot, Single Use
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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| HAO | Instrument, Surgical, Non-Powered | Neurology | 882.4535 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47633 | Surgical screwdriver, single-use, non-sterile | A non-sterile, non-powered tool that fits into a screw head in order to apply rotation to tighten/loosen/remove a screw during a surgical procedure. It typically has a high-grade stainless steel shaft with a distal end dedicated to fit into a screw head that may be slotted, Phillips (cross head), Pozidriv (Supadriv), Torx, Hex (Allen), Robertson (square), spanner head (twin pins), Polydrive, or one-way (clutch). The proximal end of the shaft may have a handle for manual use, or it may have a profiled tang that fits into an interchangeable screwdriver handle, a manually-operated chuck, or a power driver. This is a single-use device intended to be sterilized prior to use. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | G28433302 | HIBCC |