Duns Number:054875224
Device Description: Hader Bar KitKit contains:2 Hader Plastic Bar Patterns (Standard) 6 Hader Yellow Riders-St Hader Bar KitKit contains:2 Hader Plastic Bar Patterns (Standard) 6 Hader Yellow Riders-Standard6 Hader Green Processing Spacers1 Hader Insertion Tool
Catalog Number
0101701
Brand Name
Preat Implant Prosthetics
Version/Model Number
0101701
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
EGG
Product Code Name
Attachment, Precision, All
Public Device Record Key
695ae9f6-c300-4e64-b655-1a707c506a4f
Public Version Date
October 27, 2022
Public Version Number
1
DI Record Publish Date
October 19, 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 | 958 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1846 |