Duns Number:068586441
Device Description: Tongue Depressor N/S Wood 5.5" Junior, 500/Bx
Catalog Number
782020
Brand Name
Dealmed
Version/Model Number
782020
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)
-
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
f0a673a8-c3a5-480d-a2bb-5d63e2f30a72
Public Version Date
September 20, 2021
Public Version Number
2
DI Record Publish Date
November 24, 2020
Package DI Number
10859140003528
Quantity per Package
10
Contains DI Package
00859140003521
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 | 37 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6 |