Duns Number:557793214
Device Description: Biotem IR FIXTURE 6.0mm(D)X4.8mm(Body)x2.0mm(Cuff)x7.5mm(L)
Catalog Number
-
Brand Name
Biotem
Version/Model Number
FXIR4807W
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K171185
Product Code
DZE
Product Code Name
Implant, Endosseous, Root-Form
Public Device Record Key
920edac0-8ed8-4492-a1e7-63aff0ea1966
Public Version Date
July 06, 2018
Public Version Number
2
DI Record Publish Date
June 01, 2018
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 | 164 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 378 |