Duns Number:835465063
Device Description: ENDOTRACH TUBE 7060500 LASER SHLD 8MM
Catalog Number
-
Brand Name
Laser-Shield®
Version/Model Number
7060500
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 24, 2019
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
K901016
Product Code
GEX
Product Code Name
Powered laser surgical instrument
Public Device Record Key
a593142f-4ed3-4c8a-8f82-aa79412bf766
Public Version Date
June 04, 2019
Public Version Number
4
DI Record Publish Date
May 05, 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 | 665 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1575 |
| 3 | A medical device with high risk that requires premarket approval | 6 |
| U | Unclassified | 10 |