Duns Number:007883297
Device Description: Each, Bone Curette, 2.25mm, 220mm
Catalog Number
-
Brand Name
Angled Up Cup, Straight Handle, 2.25mm diameter, 220mm
Version/Model Number
N2104
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FZS
Product Code Name
Curette, Surgical, General Use
Public Device Record Key
528b2c68-699a-4720-89ef-47c100c9aa8f
Public Version Date
May 07, 2019
Public Version Number
3
DI Record Publish Date
June 29, 2016
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 | 1640 |
2 | A medical device with a moderate to high risk that requires special controls. | 288 |