Duns Number:044611812
Device Description: Ponsky-Gauderer Silicone PEG Kit 20F
Catalog Number
000329
Brand Name
Ponsky-Gauderer Silicone PEG Tray
Version/Model Number
000329
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"
Yes
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
Yes
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
e0ed4a26-28bd-452d-81ee-0a136daf5520
Public Version Date
April 20, 2020
Public Version Number
4
DI Record Publish Date
September 24, 2015
Package DI Number
10801741080903
Quantity per Package
2
Contains DI Package
00801741080906
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CA
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 36 |
2 | A medical device with a moderate to high risk that requires special controls. | 3348 |
U | Unclassified | 8 |