Duns Number:007198742
Device Description: 550 Micron TFL Single Use Fiber, 5/Box
Catalog Number
-
Brand Name
Soltive
Version/Model Number
TFL-FBX550S
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
K183647,K183647
Product Code
GEX
Product Code Name
Powered laser surgical instrument
Public Device Record Key
d8061419-c055-4f7a-836c-b7ffe671efda
Public Version Date
May 15, 2020
Public Version Number
1
DI Record Publish Date
May 07, 2020
Package DI Number
00821925044036
Quantity per Package
5
Contains DI Package
00821925044043
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 899 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1586 |
| 3 | A medical device with high risk that requires premarket approval | 9 |
| U | Unclassified | 4 |