Duns Number:068586441
Device Description: Tongue Depressor Sterile Wood 5 1/2" Junior 1's, 100/Bx
Catalog Number
782023
Brand Name
Dealmed
Version/Model Number
782023
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"
Yes
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FMA
Product Code Name
DEPRESSOR, TONGUE, NON-SURGICAL
Public Device Record Key
afc20107-ed52-44cc-8aae-ece5ba8651d0
Public Version Date
November 18, 2020
Public Version Number
1
DI Record Publish Date
November 10, 2020
Package DI Number
00817415020208
Quantity per Package
10
Contains DI Package
00817415020192
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 | 37 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6 |