Duns Number:825673239
Device Description: PUGGLE™ G-Tube16 Fr. 20 mL GASTROSTOMY TUBE WITH Y-PORTS
Catalog Number
PLG16-20
Brand Name
PUGGLE™ G-Tube
Version/Model Number
1
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 20, 2018
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"
Yes
For Single-Use
Yes
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
KNT
Product Code Name
Tubes, Gastrointestinal (And Accessories)
Public Device Record Key
2d2cf3ee-662a-4c22-aead-96ae19df3e24
Public Version Date
September 20, 2018
Public Version Number
2
DI Record Publish Date
May 10, 2018
Package DI Number
30704411007290
Quantity per Package
1
Contains DI Package
40704411007297
Package Discontinue Date
September 20, 2018
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 | 89 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 411 |
| U | Unclassified | 1 |