Duns Number:305524696
Device Description: SabreLine Single Use Laser Fiber 365um
Catalog Number
SUE365
Brand Name
Coloplast
Version/Model Number
SUE365
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
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
K182831,K182831
Product Code
GEX
Product Code Name
Powered laser surgical instrument
Public Device Record Key
a1a8d556-08b6-42ee-b92e-3abd059f0ded
Public Version Date
April 07, 2021
Public Version Number
2
DI Record Publish Date
October 03, 2019
Package DI Number
05708932688369
Quantity per Package
3
Contains DI Package
05708932688352
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Retail box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 46 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 899 |
| 3 | A medical device with high risk that requires premarket approval | 72 |
| U | Unclassified | 7 |