Duns Number:825137818
Device Description: RUBBER DAM GRN HVY LATEX 5X5
Catalog Number
9508118
Brand Name
Darby Dental Supply, LLC
Version/Model Number
9508118
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)
Yes
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
EIE
Product Code Name
DAM, RUBBER
Public Device Record Key
8992ea17-6a61-4cc5-a01e-63aa40b6e573
Public Version Date
May 10, 2022
Public Version Number
1
DI Record Publish Date
May 02, 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 | 1457 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 194 |
| U | Unclassified | 2 |