FDA UDI
In Commercial Distribution
🇺🇸 United States
Pall LaparoShield® Plus Laparoscopic Smoke Filtration System
DI: 05034480308979
·
Model: LSF1
·
Pall International Sàrl
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Pall LaparoShield® Plus Laparoscopic Smoke Filtration System
- Primary DI
- 05034480308979
- Version / Model
- LSF1
- Catalog Number
- LSF1
- Company Name
- Pall International Sàrl
- Labeler DUNS
- 485050483
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-07-20
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 80db2ef7-5a8e-45b4-8df3-a199bea87b11
Device Description
Laparoscopic Smoke Filtration System
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
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- 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 |
|---|---|---|---|---|
| FYD | APPARATUS, EXHAUST, SURGICAL | General, Plastic Surgery | 878.5070 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60836 | Laparoscopic plume filter | A sterile device intended to be used during minimally-invasive surgery, in particular laparoscopic surgery, to filter surgical smoke (plume created by, e.g., electrosurgical diathermy, a laser or sonic scalpel) of potentially harmful agents (e.g., noxious chemicals, particulates, viruses, bacteria) without loss of pneumoperitoneum. It is typically a multi-layered filter pouch intended to be connected to a trocar stopcock; it is intended to help protect surgical staff from ambient exposure to potentially harmful agents. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 35034480308970 | GS1 | case | 10 | In Commercial Distribution | |
| Primary | 05034480308979 | GS1 |
Customer Contacts
- Phone
- +1(800)645-6578 ext. 5164843600
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | >99.999% airborne particulate, bacterial and viral reduction efficiency |