Duns Number:315018218
Device Description: SQ.LINE Bone Curette, straight, 11 3/4", (300 mm), ergonomic handle, width: 15 mm, non-ste SQ.LINE Bone Curette, straight, 11 3/4", (300 mm), ergonomic handle, width: 15 mm, non-sterile, reusable, 1 piece
Catalog Number
FK698NR
Brand Name
SQ.LINE
Version/Model Number
FK698NR
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
FZS
Product Code Name
CURETTE, SURGICAL, GENERAL USE
Public Device Record Key
84799c76-5eff-468f-b2f6-b45f33016612
Public Version Date
August 26, 2020
Public Version Number
2
DI Record Publish Date
May 20, 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 |