Duns Number:315018218
Device Description: WESTCOTT Carving Instrument, 7" (175 mm), double ended, ergonomic handle, peek handle, Fig WESTCOTT Carving Instrument, 7" (175 mm), double ended, ergonomic handle, peek handle, Fig. 21B, green
Catalog Number
DF251R
Brand Name
AESCULAP
Version/Model Number
DF251R
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 23, 2021
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
EKH
Product Code Name
CARVER, DENTAL AMALGAM, OPERATIVE
Public Device Record Key
e5fbfc2f-4396-42a8-a36c-8b3dd5974457
Public Version Date
May 28, 2021
Public Version Number
2
DI Record Publish Date
June 17, 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 |