Duns Number:171843584
Device Description: Barrier Protection Fits Chayes and Segmented Ritter B Trays
Catalog Number
-
Brand Name
PATTERSON
Version/Model Number
070850644
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
MMP
Product Code Name
Cover, Barrier, Protective
Public Device Record Key
214eb21e-eade-4e31-a69d-c258183e4168
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 23, 2016
Package DI Number
D6620708506444
Quantity per Package
4
Contains DI Package
D6620708506442
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 | 16 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 145 |
| U | Unclassified | 9 |