Duns Number:985596830
Device Description: Locking Bolt Ø6 x 105mm
Catalog Number
LB02-60105
Brand Name
Apex
Version/Model Number
LB02-60105
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
HWC
Product Code Name
Screw, Fixation, Bone
Public Device Record Key
8157ccae-fdc1-4197-8ffd-2f81607510db
Public Version Date
August 22, 2022
Public Version Number
1
DI Record Publish Date
August 12, 2022
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 | 88 |
2 | A medical device with a moderate to high risk that requires special controls. | 584 |