FDA UDI
In Commercial Distribution
🇺🇸 United States
Ultimate Endo Retrieval pouch
DI: 05051223025665
·
Model: PS3443ULT
·
PURPLE SURGICAL INTERNATIONAL LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Ultimate Endo Retrieval pouch
- Primary DI
- 05051223025665
- Version / Model
- PS3443ULT
- Catalog Number
- PS3443ULT
- 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
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 39e77e94-c587-47fa-a38b-d928b8eb9d87
Device Description
The Ultimate Endo Retrieval Pouch is used during laparoscopic procedures for retrieving tissue specimens from the abdominal cavity.
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
- Yes
- 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 |
|---|---|---|---|---|
| KGY | Bag, Intestine | General, Plastic Surgery | 878.4100 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45130 | Tissue extraction bag | An impervious, flexible, sterile container intended to be used during minimally-invasive, typically keyhole, surgical techniques (e.g., laparoscopic) to extract dissected patient body tissue. The device is inserted into the body through a large bore cannula port, and the tissue to be extracted is placed in the bag with trans-cannula instruments and evacuated through the cannula. The device typically includes an x-ray detectable thread. This device may be used for surgical interventions such as an appendectomy, colonectomy, lymphadenectomy, or gallbladder removal. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 55051223025660 | GS1 | shipping carton | 50 | In Commercial Distribution | |
| Package | 35051223025666 | GS1 | shelf box | 5 | In Commercial Distribution | |
| Primary | 05051223025665 | GS1 |
Customer Contacts
- Phone
- +441923839333
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 180 | Millimeter | |
| Width | 130 | Millimeter | |
| Total Volume | 580 | Milliliter |