FDA UDI
In Commercial Distribution
🇺🇸 United States
Harmonic
DI: 10705036035770
·
Model: HAR736
·
ETHICON ENDO-SURGERY, LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- Harmonic
- Primary DI
- 10705036035770
- Version / Model
- HAR736
- Catalog Number
- HAR736
- Company Name
- ETHICON ENDO-SURGERY, LLC
- Labeler DUNS
- 044606982
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-03-01
- Public Version
- 1
- Public Version Date
- 2024-03-11
- Public Version Status
- New
- Public Device Record Key
- 28d2dfb1-fdaa-4751-843d-84b25795d8f5
Device Description
Harmonic 700 Shears, Advanced Hemostasis
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
- No
- 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 |
|---|---|---|---|---|
| LFL | Instrument, ultrasonic surgical | Unknown | U |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44755 | 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20705036035777 | GS1 | BOX | 6 | In Commercial Distribution | |
| Primary | 10705036035770 | GS1 | ||||
| Package | 30705036035774 | GS1 | CASE | 12 | In Commercial Distribution |
Customer Contacts
- Phone
- +1(877)384-4266
- [email protected]
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 5 – 90 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- High: 30 Degrees Celsius