FDA UDI
In Commercial Distribution
🇺🇸 United States
Senhance Ultrasonic
DI: 00815440021573
·
Model: X9007620
·
Asensus Surgical, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Senhance Ultrasonic
- Primary DI
- 00815440021573
- Version / Model
- X9007620
- Catalog Number
- 300-11011
- Company Name
- Asensus Surgical, Inc.
- Labeler DUNS
- 969118900
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-02-04
- Public Version
- 2
- Public Version Date
- 2022-07-11
- Public Version Status
- Update
- Public Device Record Key
- 4bfd182c-1b7e-4c7f-9bd6-5374d141ac5f
Device Description
Senhance Ultrasonic Transducer
Device Characteristics
- Single Use
- No
- 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
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| NAY | System, Surgical, Computer Controlled Instrument | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61828 | Soft-tissue ultrasonic surgical system transducer/tip | A non-sterile component of an ultrasonic surgical system intended to convert high frequency electrical current from a generator into an ultrasonic oscillation at its distal tip to mechanically fragment soft-tissue cells upon contact for cutting and/or coagulating tissue during surgery. The tip makes direct (vibrating) patient contact and the device is typically used with a holder for the operator (not included). This is a non-dedicated device intended to be used in multiple clinical specialties. This is a reusable device intended to be sterilized prior to use. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00815440021573 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K182421 | 000 |