Duns Number:081334746
Device Description: Radio Balfour 83x127mm Ba No Lip
Catalog Number
-
Brand Name
Thompson
Version/Model Number
SO6653
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
GAD
Product Code Name
Retractor
Public Device Record Key
4859bbf7-06eb-463f-be5a-bcc12c38d1b5
Public Version Date
August 15, 2022
Public Version Number
2
DI Record Publish Date
January 06, 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 | 4041 |
2 | A medical device with a moderate to high risk that requires special controls. | 135 |