Duns Number:342243334
Device Description: TI HBS self-drilling high compression _x000D_screw,cannulated,16mm,5 pcs./unit _x0 TI HBS self-drilling high compression _x000D_screw,cannulated,16mm,5 pcs./unit _x000D_
Catalog Number
-
Brand Name
mahe medical GmbH
Version/Model Number
HBS-1002-16S-ST5
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)
-
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
5b03ad4b-f824-45e5-8b99-b00b781a46d1
Public Version Date
November 13, 2019
Public Version Number
1
DI Record Publish Date
November 05, 2019
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 | 19 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1976 |