Harmonic Focus
- Primary DI
- 30705036014663
- Brand
- Harmonic Focus
- Company
- ETHICON ENDO-SURGERY, LLC
- Model
- HAR9F
- Catalog number
- HAR9F
- Device description
- Harmonic Focus Shears 9cm length + Adaptive Tissue Technology For Use With BLUE Hand Piece Only
- Published
- 2016-07-15
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
Product Codes
| Code | Name |
|---|
| LFL | Instrument, ultrasonic surgical |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| LFL | Instrument, Ultrasonic Surgical | Unknown | U |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 30705036014663 | Package | GS1 | 36 | In Commercial Distribution |
| 20705036014666 | Primary | GS1 | 0 | |
| 10705036014669 | Unit of Use | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized |
|---|
| 30705036014663 | 30705036014663 |
| 20705036014666 | 20705036014666 |
| 10705036014669 | 10705036014669 |
GMDN Terms
| Term | Definition |
|---|
| Soft-tissue ultrasonic surgical system handpiece tip, single-use | A sterile removable endpiece intended to be attached to an ultrasonic surgical system handpiece, and makes contact with a patient while oscillating (vibrating) at high frequency in order to fragment soft-tissue cells for cutting and/or coagulating tissue during surgery. The device comes in a variety of forms (e.g., blade, cylinder, pincers) and sizes, and is typically made of metal; it is not intended to be held directly (i.e., does not include a holder). This device is utilized in a variety of surgical disciplines (e.g., neurosurgery, general surgery, surgical oncology, gynaecology, and urology). This is a single-use device. |
Storage And Handling
| Type | Low | High | Condition |
|---|
| Storage Environment Humidity | 10 Percent (%) Relative Humidity | 80 Percent (%) Relative Humidity | |
| Storage Environment Temperature | -22 Degrees Celsius | 60 Degrees Celsius | |
Regulatory Flags
- DUNS number
- 044606982
- Device count
- 6
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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