Duns Number:838734093
Device Description: Screw - Ø2.0 mm x 6 mm [5 PK]
Catalog Number
SCR4-06-05[US]
Brand Name
Bioplate®
Version/Model Number
SCR4-06-05[US]
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"
-
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
K953273,K953273
Product Code
JEY
Product Code Name
Plate, Bone
Public Device Record Key
8863e503-b0b7-4a1d-a03d-8d36bc78c0db
Public Version Date
February 23, 2022
Public Version Number
4
DI Record Publish Date
June 10, 2016
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 | 198 |
2 | A medical device with a moderate to high risk that requires special controls. | 506 |