Duns Number:002348191
Device Description: HURST TUNGSTEN FILLED BOUGIE 58FR
Catalog Number
507614
Brand Name
PILLING
Version/Model Number
IPN008032
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
d508d559-9aa3-401f-8929-f46ca26a41c5
Public Version Date
June 30, 2020
Public Version Number
6
DI Record Publish Date
September 16, 2016
Package DI Number
44026704417221
Quantity per Package
10
Contains DI Package
24026704417227
Package Discontinue Date
June 26, 2020
Package Status
Not in Commercial Distribution
Package Type
Box
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 3195 |
2 | A medical device with a moderate to high risk that requires special controls. | 13747 |
3 | A medical device with high risk that requires premarket approval | 3 |
U | Unclassified | 26 |