Duns Number:009051723
Device Description: The Uni-Wedge is a plastic wedge that is meant to replace standard wooden wedges. The Uni- The Uni-Wedge is a plastic wedge that is meant to replace standard wooden wedges. The Uni-Wedges are flexible, made of plastic and will not break or splinter. Designed with finder grips to facilitate use. Each box contains 250 wedges.
Catalog Number
-
Brand Name
Uni-Wedge, Regular
Version/Model Number
93852
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
EIF
Product Code Name
Accessories, Retractor, Dental
Public Device Record Key
611c0b13-0581-4d93-a624-b547bae5e0ca
Public Version Date
August 01, 2019
Public Version Number
1
DI Record Publish Date
July 24, 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 | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |