Duns Number:315018218
Device Description: DAVIS-BOYLE Tongue Depressor, frame, for children, non-sterile, reusable
Catalog Number
OM118R
Brand Name
AESCULAP
Version/Model Number
OM118R
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"
-
For Single-Use
-
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
FMA
Product Code Name
DEPRESSOR, TONGUE, NON-SURGICAL
Public Device Record Key
5ef2eeed-c2ed-46d4-b46f-a55855e729ef
Public Version Date
April 30, 2020
Public Version Number
1
DI Record Publish Date
April 22, 2020
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 | 11840 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 7088 |
| 3 | A medical device with high risk that requires premarket approval | 37 |