Duns Number:427895198
Device Description: The Sterile shield LAF 02-D is a single-use sterile consumable to be used together with ul 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.
Catalog Number
-
Brand Name
Sterile Shield
Version/Model Number
LAF-02-D
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
ORC
Product Code Name
Air Filter Portable Apparatus
Public Device Record Key
a44b1f2f-e318-4217-94d3-156f62ecc8af
Public Version Date
June 22, 2021
Public Version Number
3
DI Record Publish Date
December 20, 2019
Package DI Number
07350101640050
Quantity per Package
2
Contains DI Package
07350101640067
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Cardbordbox
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |