Duns Number:119193803
Device Description: Blue PRACTIfilm Barrier Cling Sheets are a simple solution to contamination control. Thinn Blue PRACTIfilm Barrier Cling Sheets are a simple solution to contamination control. Thinner 1.5 mil polyethylene and special low-tack adhesive give PRACTIfilm the ideal cling quality. Each 4" x 6" sheet sticks anywhere yet removes easily, leaving no residue. 1,200 perforated sheets per roll in a convenient dispenser box.
Catalog Number
704223
Brand Name
PRACTIfilm Barrier Cling Sheets Blue
Version/Model Number
704223 4X6 Blue Film
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
K151123,K151123,K151123
Product Code
PEM
Product Code Name
Dental Barriers And Sleeves
Public Device Record Key
64a79b46-a2e2-408c-b7f1-8857d1929ffc
Public Version Date
August 24, 2020
Public Version Number
1
DI Record Publish Date
August 14, 2020
Package DI Number
00723896018170
Quantity per Package
20
Contains DI Package
00723896018163
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 93 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |