Duns Number:315018218
Device Description: WAGNER SQ.LINE Raspatory, curved, 15 3/4", (400 mm), sharp, rounded blade, ergonomic handl WAGNER SQ.LINE Raspatory, curved, 15 3/4", (400 mm), sharp, rounded blade, ergonomic handle, width: 17 mm, non-sterile, reusable
Catalog Number
FK425NR
Brand Name
SQ.LINE
Version/Model Number
FK425NR
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
HTR
Product Code Name
RASP
Public Device Record Key
1e4af049-ce5c-4423-8f14-4949d184db26
Public Version Date
June 10, 2022
Public Version Number
4
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 |