Duns Number:610712213
Device Description: LUCENT® L SNAP-ON SLED, 10MM
Catalog Number
-
Brand Name
Lucent-L
Version/Model Number
11824-602
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 19, 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
-
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
LXH
Product Code Name
Orthopedic Manual Surgical Instrument
Public Device Record Key
3d3b734b-cbbf-4285-8695-daa65e16465e
Public Version Date
December 20, 2019
Public Version Number
2
DI Record Publish Date
November 20, 2019
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 | 4289 |
2 | A medical device with a moderate to high risk that requires special controls. | 2600 |