Duns Number:948025002
Device Description: #0 Cup Curette, Parallel Bayonet 90° REV ANG DWM
Catalog Number
-
Brand Name
Life Instruments
Version/Model Number
514-1500-2D-1
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)
-
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
5ebfac26-d5a9-4536-94cb-e8ee2c1539c6
Public Version Date
November 15, 2021
Public Version Number
1
DI Record Publish Date
November 05, 2021
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 | 5454 |
2 | A medical device with a moderate to high risk that requires special controls. | 7 |