FDA UDI
In Commercial Distribution
🇺🇸 United States
EndoWrist;daVinci Si
DI: 00886874111161
·
Model: 420003
·
INTUITIVE SURGICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- EndoWrist;daVinci Si
- Primary DI
- 00886874111161
- Version / Model
- 420003
- Company Name
- INTUITIVE SURGICAL, INC.
- Labeler DUNS
- 938647021
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-07-08
- Public Version
- 19
- Public Version Date
- 2021-06-14
- Public Version Status
- Update
- Public Device Record Key
- f2700664-06dd-4436-a2f9-9ccf7f51ffa2
Device Description
SMALL CLIP APPLIER
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
- No
- 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 |
|---|---|---|---|---|
| 64401 | Robotic surgical ligation clip applier | A surgical device intended to be used in conjunction with a robotic surgical system to apply small atraumatic clips (not included) for the ligation of blood vessels, or similar tubular anatomy, mainly to prevent and/or stop bleeding (i.e., haemostasis) during a robotic endoscopic (e.g., laparoscopic) procedure. It may also be used to apply small clamps (e.g., bulldog type) to tissues, however it is not intended to apply an aneurysm clip. The device is typically a metallic instrument with flat, curved ends to hold and deliver the clips (e.g., forceps-like) and a proximal housing intended to be connected directly to an arm of the robotic surgical system. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00886874111161 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 8 | Millimeter |