Duns Number:775295061
Device Description: MIXPAC™ Protective Sleeves provide convenient and effective barrier protection of multi-us MIXPAC™ Protective Sleeves provide convenient and effective barrier protection of multi-use application systems to protectthe dentist, staff and patient against cross-contamination and infectious disease during clinical use.
Catalog Number
PRS 701-03
Brand Name
MIXPAC Protective Sleeve
Version/Model Number
5 ml
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
K211026,K211026
Product Code
PEM
Product Code Name
Dental Barriers And Sleeves
Public Device Record Key
63dc1f44-7540-4a7e-ac6a-afa61243bc6b
Public Version Date
October 11, 2022
Public Version Number
1
DI Record Publish Date
October 03, 2022
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |