Duns Number:021323706
Catalog Number
ASTS-SA-LG2414-SP
Brand Name
4WEB Medical
Version/Model Number
ASTS-SA-LG2414-SP
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
OVD
Product Code Name
Intervertebral Fusion Device With Integrated Fixation, Lumbar
Public Device Record Key
b70c091c-5d98-48d1-9e4f-2cae4a5922f7
Public Version Date
December 02, 2021
Public Version Number
1
DI Record Publish Date
November 24, 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 | 1166 |
2 | A medical device with a moderate to high risk that requires special controls. | 1198 |