FDA UDI
In Commercial Distribution
🇺🇸 United States
DYONICS POWER
DI: 03596010469724
·
Model: 7209397
·
Smith & Nephew, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- DYONICS POWER
- Primary DI
- 03596010469724
- Version / Model
- 7209397
- Catalog Number
- 7209397
- Company Name
- Smith & Nephew, Inc.
- Labeler DUNS
- 045483575
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-08-30
- Public Version
- 4
- Public Version Date
- 2023-09-07
- Public Version Status
- Update
- Public Device Record Key
- 7370e8c5-b776-42c6-9da4-7173b84def85
Device Description
SAW BLADE 5.8MM X 18MM X 0.4MM
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 |
|---|---|---|---|---|
| 43376 | Surgical saw blade, sagittal, single-use | A flat surgical cutting instrument, usually made of high-grade stainless steel, with a serrated edge designed for attachment to a dedicated powered saw used for cutting bone/tissue during orthopaedic or oral surgery; it is not dedicated to cutting through the sternum (i.e., not a sternum saw blade). This device is designed with the cutting teeth arranged in an arc or on a flat plane pointing directly forward at the distal end to cut in a rapid sagittal (side to side) motion; it may in addition cut in an oscillating motion. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03596010469724 | GS1 | ||||
| Package | 23596010469728 | GS1 | BX | 6 | In Commercial Distribution |
Customer Contacts
- Phone
- +1(800)238-7538
- [email protected]