FDA UDI
In Commercial Distribution
🇺🇸 United States
Senhance Ultrasonic
DI: 00815440021580
·
Model: X9007621
·
Asensus Surgical, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Senhance Ultrasonic
- Primary DI
- 00815440021580
- Version / Model
- X9007621
- Catalog Number
- 300-01010
- 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
- 9b1d9364-1024-48e9-9a07-9eedac8ec4c6
Device Description
Senhance Ultrasonic Generator
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
- No
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 |
|---|---|---|---|---|
| 57825 | Electrosurgical/ultrasonic surgical system generator | A mains electricity-powered (AC-powered) device designed to provide high frequency electrical current to power connected electrosurgical diathermy instruments (create heat within tissues) and ultrasonic surgical instruments (rapidly vibrate tissues), enabling a combination of methods to cut and/or coagulate tissues during open or laparoscopic surgery; the instruments are not included. The device may be used for various types of surgery (e.g., general, gynaecological, plastic); it is typically regulated by the operator with a hand- or foot-switch. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00815440021580 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K182421 | 000 |