Duns Number:010316284
Device Description: LASE Endoscopic Discectomy System (Long), with Tubing Set. For use with HO:YAG lasers wit LASE Endoscopic Discectomy System (Long), with Tubing Set. For use with HO:YAG lasers with a Trimedyne connector.
Catalog Number
1100-010L
Brand Name
LASE Endoscopic Discectomy Set
Version/Model Number
1100-010L
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
K922881
Product Code
GEX
Product Code Name
Powered Laser Surgical Instrument
Public Device Record Key
73ac4f2a-ce93-42e4-bb04-825b69ab7b09
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 20, 2016
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 | 12 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 22 |