Duns Number:009260217
Device Description: Retrax System retraction cord packing instruments are stainless steel. They have a larger Retrax System retraction cord packing instruments are stainless steel. They have a larger, round handle and the handle is stainless steel with a black electroplate finish. The tips are polished stainless steel.
Catalog Number
26121
Brand Name
Retrax System R-50
Version/Model Number
26121
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)
-
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
b580fb65-3454-4838-94d7-19378dbed600
Public Version Date
May 17, 2022
Public Version Number
1
DI Record Publish Date
May 09, 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 | 34 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6 |
| U | Unclassified | 57 |