Duns Number:092987189
Device Description: CURETTE COAKLEY SMALL STRONG CURVE
Catalog Number
51-2750 5
Brand Name
JEDMED
Version/Model Number
51-2750 5
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
KAP
Product Code Name
Curette, Nasal
Public Device Record Key
611670e1-9230-467d-9091-fdf42f7f4504
Public Version Date
September 09, 2020
Public Version Number
1
DI Record Publish Date
September 01, 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 | 871 |
2 | A medical device with a moderate to high risk that requires special controls. | 127 |
U | Unclassified | 11 |