Catalog Number
-
Brand Name
None
Version/Model Number
430075
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
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
-
Product Code
NAY
Product Code Name
System, surgical, computer controlled instrument
Public Device Record Key
6a7f167b-7f0d-4700-a580-073b303a0440
Public Version Date
March 19, 2021
Public Version Number
1
DI Record Publish Date
March 11, 2021
Package DI Number
10886874119553
Quantity per Package
6
Contains DI Package
00886874119556
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 1 |
2 | A medical device with a moderate to high risk that requires special controls. | 376 |