FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Mini Port
DI: 20884521066288
·
Model: 171312
·
Covidien LP
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Mini Port
- Primary DI
- 20884521066288
- Version / Model
- 171312
- Catalog Number
- 171312
- Company Name
- Covidien LP
- Labeler DUNS
- 058614483
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-29
- Public Version
- 4
- Public Version Date
- 2022-09-05
- Public Version Status
- Update
- Public Device Record Key
- 0e61b4df-06ad-429f-9838-38f4b7ead5f8
- Distribution End Date
- 2022-03-11
Device Description
Sleeve
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 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37148 | Laparoscopic access cannula, reusable | A single-lumen surgical device intended to be percutaneously inserted through the abdominal wall to create an access port for a laparoscope/laparoscopic instrument during laparoscopy. The cannula is often provided with a shut-off valve for gas/fluid supply, and other sealing devices (e.g., dedicated seals/rings, caps, valves), to prevent insufflation gas leakage whilst allowing entry of instruments. It may include a sharp or blunt trocar blade to assist introduction and/or puncture the abdominal wall; if the trocar is included it may be referred to as a trocar or trocar assembly. It is available in a variety of dimensions and/or designs. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10884521066281 | GS1 | CASE | 12 | Not in Commercial Distribution | 2022-03-11 |
| Primary | 20884521066288 | GS1 |
Customer Contacts
- Phone
- +1(508)261-8000
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K862611 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 2 | Millimeter |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- – 130 Degrees Fahrenheit