Duns Number:315018218
Device Description: HI-LINE XS DISP.ROSEN BURR II+ D2.3MM
Catalog Number
GE574SU
Brand Name
HI-LINE XS
Version/Model Number
GE574SU
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 09, 2022
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
Yes
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
GEY
Product Code Name
MOTOR, SURGICAL INSTRUMENT, AC-POWERED
Public Device Record Key
c7e98c2f-6fc8-47a4-a4d1-cd1a233ed471
Public Version Date
March 17, 2022
Public Version Number
1
DI Record Publish Date
March 09, 2022
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 |