FDA UDI
In Commercial Distribution
🇺🇸 United States
DYONICS HELICUT
DI: 03596010404664
·
Model: 7205727
·
Smith & Nephew, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- DYONICS HELICUT
- Primary DI
- 03596010404664
- Version / Model
- 7205727
- Catalog Number
- 7205727
- Company Name
- Smith & Nephew, Inc.
- Labeler DUNS
- 045483575
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-10-05
- Public Version
- 8
- Public Version Date
- 2023-09-07
- Public Version Status
- Update
- Public Device Record Key
- 849eb53e-075b-475d-b792-bf1d94ae9d02
Device Description
4.5 MM HELICUT STRAIGHT BURRS, POWER/EP-1, SLATE, 5000 MAXIMUM RPM, PACKAGED 6 PER BOX, STERILE
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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
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 |
|---|---|---|---|---|
| 41499 | Arthroscopic shaver system blade, single-use | A cutting device designed for use in a powered arthroscopic shaver system handpiece (not included) for bone and soft-tissue resection during arthroscopic surgery on a joint (e.g., a knee, shoulder, or ankle). It is locked into the handpiece, and typically consists of a small outer tube with a hub and a rotating inner tube with a connector that performs a rotational or reciprocating (back and forth) motion. It is typically made of high-grade stainless steel. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 23596010404668 | GS1 | BX | 6 | In Commercial Distribution | |
| Primary | 03596010404664 | GS1 |
Customer Contacts
- Phone
- +1(800)238-7538
- [email protected]