FDA UDI
In Commercial Distribution
🇺🇸 United States
Senhance Ultrasonic
DI: 00815440021566
·
Model: X9007619
·
Asensus Surgical, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Senhance Ultrasonic
- Primary DI
- 00815440021566
- Version / Model
- X9007619
- Catalog Number
- 300-11010
- 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
- 3
- Public Version Date
- 2022-07-11
- Public Version Status
- Update
- Public Device Record Key
- d13a3cc4-a254-4442-bbfc-426f190cecd5
Device Description
Senhance Ultrasonic Dissector
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 |
|---|---|---|---|---|
| NAY | System, Surgical, Computer Controlled Instrument | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63120 | Soft-tissue ultrasonic robotic surgical instrument, single-use | A sterile component of an ultrasonic surgical assembly intended to be connected directly to the arm of a robotic surgical system, and convert high frequency electrical current from a generator into an ultrasonic oscillation for a tip placed at its end to mechanically fragment soft-tissue cells upon contact during robotic endoscopic (e.g., laparoscopic, arthroscopic) surgery. It is typically in the form of an elongated probe with a proximal housing intended to attach to the robotic arm. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00815440021566 | GS1 | ||||
| Package | 10815440021563 | GS1 | Case | 10 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K182421 | 000 |