Duns Number:534128491
Device Description: Package of Plastic Snaps Transfer with Abutment-10 units
Catalog Number
D4-3.75,1Pack
Brand Name
Tools
Version/Model Number
D4-3.75,1Pack
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
-
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
NDP
Product Code Name
Accessories, Implant, Dental, Endosseous
Public Device Record Key
671b0354-1b90-452c-bd91-17d9086d51f6
Public Version Date
October 07, 2019
Public Version Number
1
DI Record Publish Date
September 29, 2019
Package DI Number
17290111270601
Quantity per Package
10
Contains DI Package
07290111270604
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
bag
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 190 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 276 |