FDA UDI
In Commercial Distribution
🇺🇸 United States
DYONICS
DI: 00885554033595
·
Model: 72204128
·
Smith & Nephew, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- DYONICS
- Primary DI
- 00885554033595
- Version / Model
- 72204128
- Catalog Number
- 72204128
- Company Name
- Smith & Nephew, Inc.
- Labeler DUNS
- 045483575
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-04-12
- Public Version
- 3
- Public Version Date
- 2023-09-07
- Public Version Status
- Update
- Public Device Record Key
- b00d5f34-5456-4bda-9a61-cbfdd570cd45
Device Description
DYONICS PIN DRIVER SM BAT HANDPIECE
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| HAB | SAW, POWERED, AND ACCESSORIES | General, Plastic Surgery | 878.4820 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41781 | Surgical power tool system handpiece, wire-driving, rechargeable battery-powered | A battery-powered, drill-like, machine intended to be used for the sole purpose of driving in orthopaedic bone wires, e.g., Steinmann pins, Kirschner wires or K-Wires (thin needle-like pins of different widths that are pointed for self-drilling), into bone for the restoration of bones. This device will typically have a special gripping collet for rapid repositioning of the hold on the wire as it is fed into the bone. A rechargeable battery pack is attached to this device to provide the low-voltage electrical power. This is a reusable device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00885554033595 | GS1 |
Customer Contacts
- Phone
- +1(800)238-7538
- [email protected]