FDA UDI
In Commercial Distribution
🇺🇸 United States
Sterile Shield
DI: 07350101640067
·
Model: LAF-02-D
·
Toul Meditech AB
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
50
Basic Information
- Brand Name
- Sterile Shield
- Primary DI
- 07350101640067
- Version / Model
- LAF-02-D
- Company Name
- Toul Meditech AB
- Labeler DUNS
- 427895198
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2019-12-20
- Public Version
- 3
- Public Version Date
- 2021-06-22
- Public Version Status
- Update
- Public Device Record Key
- a44b1f2f-e318-4217-94d3-156f62ecc8af
Device Description
The Sterile shield LAF 02-D is a single-use sterile consumable to be used together with ultra clean air devices from Toul Meditech AB, to function as a sterile protection for preventing airborne contamination in the surgical environment. In addition, the sterile shield LAF 02-D has laminar character which forms the air to a parallel stream of turbulence free ultra clean air. The sterile shield LAF 02-D is attached on the Operio device on the outlet of the HEPA filtered ultra clean air. Instructions on how to use and mount the sterile shield LAF 02-D is included in both the Operator’s manual and short form instructions. In addition, the label itself has an illustrative short form instruction.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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 |
|---|---|---|---|---|
| ORC | Air Filter Portable Apparatus | General, Plastic Surgery | 878.5070 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62934 | Surgical dressing/drape kit, single-use | A collection of various types of patient drapes, dressings, covers and/or towels intended to be used to facilitate a surgical procedure. It does not include any pharmaceuticals, surgical instruments, surgical tubing, or mechanically functional devices and is not dedicated to catheterization support. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 07350101640050 | GS1 | Cardbordbox | 2 | In Commercial Distribution | |
| Primary | 07350101640067 | GS1 | ||||
| Unit of Use | 07350101640074 | GS1 |