Duns Number:787471015
Device Description: Surgical Kit
Catalog Number
-
Brand Name
Restore
Version/Model Number
L9102-1K
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"
Yes
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
OFY
Product Code Name
Dental implant surgical tray
Public Device Record Key
f76ecf2a-2b2e-4ebb-8196-22c6bf79de2f
Public Version Date
March 25, 2021
Public Version Number
2
DI Record Publish Date
May 24, 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 | 476 |
2 | A medical device with a moderate to high risk that requires special controls. | 1336 |