FDA UDI
In Commercial Distribution
🇺🇸 United States
EndoWrist
DI: 00886874114810
·
Model: 480299
·
INTUITIVE SURGICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- EndoWrist
- Primary DI
- 00886874114810
- Version / Model
- 480299
- Company Name
- INTUITIVE SURGICAL, INC.
- Labeler DUNS
- 938647021
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-02-27
- Public Version
- 7
- Public Version Date
- 2023-12-13
- Public Version Status
- Update
- Public Device Record Key
- 421e2c4e-d338-46ad-a6bc-72cf8f8c65e7
Device Description
SUCTION IRRIGATOR
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 |
|---|---|---|---|---|
| 64426 | Robotic surgical irrigation/aspiration cannula, single-use | An atraumatic, invasive tube intended to be connected directly to the arm of a robotic surgical system and designed as a conduit to allow irrigation and aspiration (i.e., capable of both functions) of body cavities/wounds during a robotic surgical (e.g., laparoscopic) procedure, typically to facilitate observation; it may additionally be used for tissue manipulation. It is typically a long, slim, rigid tube with a proximal housing that connects to an arm of the robotic surgical system; it may include connection tubing and additional tubing set components (e.g., clamps, filters, connectors). It is not designed to administer parenteral fluids or drugs. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10886874114817 | GS1 | BOX | 6 | In Commercial Distribution | |
| Primary | 00886874114810 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 8 | Millimeter |