FDA UDI
In Commercial Distribution
🇺🇸 United States
Single-Site
DI: 00886874112724
·
Model: 478161
·
INTUITIVE SURGICAL, INC.
Product Codes
2
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Single-Site
- Primary DI
- 00886874112724
- Version / Model
- 478161
- 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
- 4
- Public Version Date
- 2020-03-02
- Public Version Status
- Update
- Public Device Record Key
- 6b563efe-42a4-4fe3-af50-f4f4fd3831f4
Device Description
CANNULA SEAL
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 |
|---|---|---|---|---|
| GCJ | Laparoscope, general & plastic surgery | Gastroenterology, Urology | 876.1500 | 2 |
| NAY | System,surgical,computer controlled instrument | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45645 | Laparoscopic access cannula seal, single-use | A small, sterile device intended to create a seal between a laparoscopic access cannula (not included) and an appropriately sized laparoscopic instrument, to inhibit the leakage of insufflation media [e.g., carbon dioxide (CO2) gas]. It is intended to be fitted directly to the proximal end of the sleeve and is typically available in a variety of sizes appropriate for given sleeve/instrument diameters. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30886874112725 | GS1 | CASE | 64 | In Commercial Distribution | |
| Package | 10886874112721 | GS1 | BOX | 10 | In Commercial Distribution | |
| Primary | 00886874112724 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Lumen/Inner Diameter | 10 | Millimeter | |
| Lumen/Inner Diameter | 5 | Millimeter |