FDA UDI
In Commercial Distribution
🇺🇸 United States
Universal Smooth Cannula
DI: 05051223015383
·
Model: PS4568ULT
·
PURPLE SURGICAL INTERNATIONAL LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Universal Smooth Cannula
- Primary DI
- 05051223015383
- Version / Model
- PS4568ULT
- Catalog Number
- PS4568ULT
- Company Name
- PURPLE SURGICAL INTERNATIONAL LIMITED
- Labeler DUNS
- 239403863
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-17
- Public Version
- 3
- Public Version Date
- 2020-01-09
- Public Version Status
- Update
- Public Device Record Key
- cce3c554-7466-4391-b6f3-4e0982116d21
Device Description
The Ultimate Cannula has applications in minimally invasive surgical procedures, and acts as a port of entry for endoscopic instruments.
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 |
|---|---|---|---|---|
| HET | Laparoscope, Gynecologic (And Accessories) | Obstetrics/Gynecology | 884.1720 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 42412 | Laparoscopic access cannula, single-use | 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 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 additionally be intended for thoracoscopy whereby the valve may not be required. 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. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 55051223015388 | GS1 | shipping carton | 20 | In Commercial Distribution | |
| Package | 35051223015384 | GS1 | shelf box | 5 | In Commercial Distribution | |
| Primary | 05051223015383 | GS1 |
Customer Contacts
- Phone
- +441923839333
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 10mm diameter x 100mm length |