Duns Number:174262477
Device Description: 1 HALF SHEET DRAPE - STERILE SEPARATE
Catalog Number
SS66952
Brand Name
STRADIS HEALTHCARE
Version/Model Number
SS66952
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
OFX
Product Code Name
General Purpose Dental Tray
Public Device Record Key
af940d89-bdf7-4ff8-affe-5c29bab2c7b6
Public Version Date
June 17, 2022
Public Version Number
2
DI Record Publish Date
March 22, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1226 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1431 |
| U | Unclassified | 10 |