Duns Number:002348191
Device Description: MALONEY TUNGSTEN FILLED BOUGIE 56 FRENCH
Catalog Number
507956
Brand Name
PILLING
Version/Model Number
IPN916178
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
6c9af875-0917-4cd0-b26b-523c52afc3bb
Public Version Date
March 19, 2021
Public Version Number
1
DI Record Publish Date
March 11, 2021
Package DI Number
24026704719925
Quantity per Package
10
Contains DI Package
14026704719928
Package Discontinue Date
-
Package Status
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 |