FDA UDI
In Commercial Distribution
🇺🇸 United States
Senhance
DI: 00815440020125
·
Model: X0007020
·
Asensus Surgical, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Senhance
- Primary DI
- 00815440020125
- Version / Model
- X0007020
- Catalog Number
- 200-11045
- Company Name
- Asensus Surgical, Inc.
- Labeler DUNS
- 969118900
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-11-27
- Public Version
- 5
- Public Version Date
- 2022-07-11
- Public Version Status
- Update
- Public Device Record Key
- 0d8509e7-a8cd-43eb-9887-cafd6cebd5ba
Device Description
Needle Holder Right
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
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| 63113 | Robotic surgical forceps, reusable | A surgical device intended to be used in conjunction with a robotic surgical system to grasp tissue (typically atraumatically) or foreign bodies during a robotic endoscopic procedure. It is designed as a long shaft with a pair of scissors-like grasping tongs or claws at the distal end, and a proximal housing intended to be connected directly to an arm of the robotic surgical system; it is not an electrosurgical instrument. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00815440020125 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K171120 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 310 | Millimeter | |
| Outer Diameter | 5 | Millimeter |