Duns Number:827608774
Device Description: LinkBio Instrument Tray (Mega C): Mega C SL Tibia Prep Instruments
Catalog Number
-
Brand Name
LinkBio Instrument
Version/Model Number
MCSLTP
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FSM
Product Code Name
Tray, Surgical, Instrument
Public Device Record Key
df5a8fa0-597c-4c5a-9386-f68e8fce3da3
Public Version Date
September 16, 2022
Public Version Number
4
DI Record Publish Date
May 13, 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 | 92 |