Duns Number:838734093
Device Description: T Plate - Ø1.5 mm - 5 hole - 15 mm
Catalog Number
81-2004[US]
Brand Name
Bioplate®
Version/Model Number
81-2004[US]
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
K002426
Product Code
JEY
Product Code Name
Plate, Bone
Public Device Record Key
7baec82f-6e85-42ea-a67c-c5ac7b0657c2
Public Version Date
February 23, 2022
Public Version Number
5
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 |