Duns Number:053950783
Device Description: LessRay Power Cord, 15ft Autolock
Catalog Number
-
Brand Name
LessRay
Version/Model Number
1675639
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
-
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
NBH
Product Code Name
Accessories, arthroscopic
Public Device Record Key
5d7513e7-6667-4dcf-a9f2-64c53d90a2a7
Public Version Date
June 23, 2021
Public Version Number
1
DI Record Publish Date
June 15, 2021
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 | 4207 |
2 | A medical device with a moderate to high risk that requires special controls. | 38751 |
3 | A medical device with high risk that requires premarket approval | 84 |
U | Unclassified | 29 |