FDA UDI
Not in Commercial Distribution
🇺🇸 United States
YelloPort Plus
DI: 05051986001357
·
Model: YA516STS
·
SURGICAL INNOVATIONS LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- YelloPort Plus
- Primary DI
- 05051986001357
- Version / Model
- YA516STS
- Company Name
- SURGICAL INNOVATIONS LIMITED
- Labeler DUNS
- 771051935
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 4
- Public Version Date
- 2020-03-30
- Public Version Status
- Update
- Public Device Record Key
- f1d887d0-2ec4-4702-98f3-5ec88aa99a9a
- Distribution End Date
- 2020-01-31
Device Description
LAPAROSCOPIC PORT ACCESS SYSTEM 5-10-16mm SwingTop + Duckbill Laparoscopic Sleeve Seal Reducer-
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- 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 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45597 | Laparoscopic access cannula seal reducer | A small device intended to reduce the sealing diameter of an existing laparoscopic access cannula seal, so laparoscopic instruments with smaller diameters can be introduced through the parent laparoscopic sleeve whilst maintaining a seal and inhibiting the leakage of insufflation media [e.g., carbon dioxide (CO2) gas]. It is intended to fit within the laparoscopic access cannula seal (fitted at the proximal end of the cannula) when required throughout the laparoscopic surgical procedure. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 05051986002279 | GS1 | Inner Box | 6 | Not in Commercial Distribution | 2020-01-31 |
| Primary | 05051986001357 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K070712 | 000 |