Duns Number:030650113
Device Description: Tungsten-Filled Hurst Esophageal Dilator, 56 French
Catalog Number
1209-56
Brand Name
WeightRight®
Version/Model Number
1209-56
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FAT
Product Code Name
Bougie, Esophageal, And Gastrointestinal, Gastro-Urology
Public Device Record Key
f08f1f59-c48b-4308-be75-84fce6ebdbc4
Public Version Date
April 10, 2019
Public Version Number
7
DI Record Publish Date
September 17, 2016
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 | 109 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 207 |