FDA UDI
Not in Commercial Distribution
🇺🇸 United States
YelloPort Plus - Laparoscopic Port Access System
DI: 05051986002422
·
Model: YA010STS
·
SURGICAL INNOVATIONS LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- YelloPort Plus - Laparoscopic Port Access System
- Primary DI
- 05051986002422
- Version / Model
- YA010STS
- 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
- 5
- Public Version Date
- 2022-04-15
- Public Version Status
- Update
- Public Device Record Key
- 2e7dc2a1-2667-4a70-87a0-a087c244db90
- Distribution End Date
- 2022-04-14
Device Description
10mm Camera Port Seal Unit & Valve
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
- 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 |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| Primary | 05051986002422 | GS1 | ||||
| Package | 05051986002439 | GS1 | Inner Box | 6 | Not in Commercial Distribution | 2022-04-14 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K070712 | 000 |