Duns Number:315018218
Device Description: VOLKMANN SQ.LINE Bone Curette, straight, 9 1/2", (240 mm), ergonomic handle, #4, width: 11 VOLKMANN SQ.LINE Bone Curette, straight, 9 1/2", (240 mm), ergonomic handle, #4, width: 11,500 mm, non-sterile, reusable, 1 piece
Catalog Number
FK647NR
Brand Name
SQ.LINE
Version/Model Number
FK647NR
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HCY
Product Code Name
CURETTE, UTERINE
Public Device Record Key
5a337140-8b26-44bc-900d-c9eb1788bd99
Public Version Date
August 18, 2020
Public Version Number
1
DI Record Publish Date
August 10, 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 | 11840 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 7088 |
| 3 | A medical device with high risk that requires premarket approval | 37 |