Duns Number:784984267
Device Description: Impression Coping, 20 Pack, Packaged, Primeloc Attachment System
Catalog Number
-
Brand Name
PrimeLoc
Version/Model Number
LOC50060-20
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
EIF
Product Code Name
Accessories, Retractor, Dental
Public Device Record Key
72f1d019-52f2-41fd-92e5-b22b0d9a1e55
Public Version Date
September 20, 2021
Public Version Number
2
DI Record Publish Date
August 17, 2020
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 | 55 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 35 |