FDA UDI
Not in Commercial Distribution
🇺🇸 United States
YelloPort Plus.tif
DI: 05051986011783
·
Model: YA05070SP
·
SURGICAL INNOVATIONS LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- YelloPort Plus.tif
- Primary DI
- 05051986011783
- Version / Model
- YA05070SP
- Company Name
- SURGICAL INNOVATIONS LIMITED
- Labeler DUNS
- 771051935
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-11-07
- Public Version
- 4
- Public Version Date
- 2020-03-30
- Public Version Status
- Update
- Public Device Record Key
- 2e0a7c92-9763-48a0-b0aa-f418eb71de78
- Distribution End Date
- 2019-12-31
Device Description
LAPAROSCOPIC PORT ACCESS SYSTEM 5.5mm x 70mm Shielded Plunger Laparoscopic trocar, reusable -
Device Characteristics
- Single Use
- No
- 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
- 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 |
|---|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61424 | Laparoscopic trocar blade, reusable | A rigid, surgical instrument with a sharp pyramidal or conical point intended to puncture the abdominal wall to facilitate the introduction of a separate laparoscopic access cannula (not included) during laparoscopy. It is intended to fill the lumen of the laparoscopic access cannula, whereby following puncture it is withdrawn to provide a single-lumen access port to the abdominal cavity. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05051986011783 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K070712 | 000 |