Duns Number:009260217
Device Description: Retraction Cord Packing Instrument Circlet with Serrated tip
Catalog Number
26130
Brand Name
R-55 Circlet Packing Instrument Serrated
Version/Model Number
26130
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)
-
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
33c79bd7-9255-4fde-a256-ab78f10262c2
Public Version Date
March 04, 2019
Public Version Number
1
DI Record Publish Date
January 31, 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 | 34 |
2 | A medical device with a moderate to high risk that requires special controls. | 6 |
U | Unclassified | 57 |