Duns Number:081334746
Device Description: Balfour 30x50mm
Catalog Number
-
Brand Name
Thompson
Version/Model Number
5570
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
5367718f-afdc-4139-bbbb-2c114e867e98
Public Version Date
May 12, 2022
Public Version Number
2
DI Record Publish Date
December 17, 2021
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 |