Duns Number:054875224
Device Description: Astra EV 5.4 Non-Engaging Verification Cylinder; . Kit contains . 1 Astra EV 5.4 Non-Engag Astra EV 5.4 Non-Engaging Verification Cylinder; . Kit contains . 1 Astra EV 5.4 Non-Engaging Verification Cylinder (00842092126806), . 1 Astra EV 5.4 Titanium Screw (00842092126943), . 1 Astra EV 5.4 Guide Pin (00842092135563)
Catalog Number
8006835
Brand Name
Astra
Version/Model Number
8006835
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
NHA
Product Code Name
Abutment, implant, dental, endosseous
Public Device Record Key
33035367-1afc-4c23-8fb2-c8dbfdaef18c
Public Version Date
November 01, 2022
Public Version Number
1
DI Record Publish Date
October 24, 2022
Package DI Number
00842092163429
Quantity per Package
10
Contains DI Package
00842092163412
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Pack
| 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 |