Duns Number:108631797
Catalog Number
27436
Brand Name
Alphatec Spine Battalion LLIF Light Cable
Version/Model Number
011043
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"
Yes
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
FDG
Product Code Name
Retractor, Fiberoptic
Public Device Record Key
02400d2f-93f0-4116-b302-ee985f12e2ac
Public Version Date
October 06, 2020
Public Version Number
1
DI Record Publish Date
September 28, 2020
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 | 120 |
2 | A medical device with a moderate to high risk that requires special controls. | 4 |