Duns Number:830350380
Device Description: CURETTE X0705066 STRAIGHT BAYANET 3.6MM
Catalog Number
-
Brand Name
N/A
Version/Model Number
X0705066
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 14, 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"
-
For Single-Use
-
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
HTF
Product Code Name
CURETTE
Public Device Record Key
99580731-6bca-4d93-8030-841aa75758aa
Public Version Date
June 10, 2022
Public Version Number
4
DI Record Publish Date
November 11, 2017
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 | 13352 |
2 | A medical device with a moderate to high risk that requires special controls. | 26085 |
3 | A medical device with high risk that requires premarket approval | 190 |
U | Unclassified | 75 |