Duns Number:010712461
Device Description: HANDLE,SUCTION,YANKAUER,STRAIGHT TIP,W/O CONTROL VENT,STERILE 50/CA
Catalog Number
-
Brand Name
Curaplex
Version/Model Number
301-005-10010
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 31, 2020
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
JOL
Product Code Name
CATHETER AND TIP, SUCTION
Public Device Record Key
6ea9d9e4-3f98-42c4-8337-2d87a719884b
Public Version Date
December 31, 2020
Public Version Number
4
DI Record Publish Date
February 06, 2017
Package DI Number
00812574026573
Quantity per Package
50
Contains DI Package
00812574026221
Package Discontinue Date
December 31, 2020
Package Status
Not 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 | 92 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 92 |