Duns Number:057728685
Device Description: Dental Dams, Natural Latex, Unflavored 5" x 5", Medium
Catalog Number
-
Brand Name
Dental Dams
Version/Model Number
19100
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)
-
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
6c465d4e-2be9-42fc-b3e5-5604e261cedd
Public Version Date
October 07, 2022
Public Version Number
1
DI Record Publish Date
September 29, 2022
Package DI Number
50732224002168
Quantity per Package
40
Contains DI Package
10732224002160
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 33 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 25 |