Duns Number:147530323
Device Description: PEG Kit Push Technique; with snare
Catalog Number
30-4020-S7
Brand Name
CORFLO PEG Kit with snare
Version/Model Number
30-4020-S7
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
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
b7d35470-1007-4646-b0eb-c6c7bf333d71
Public Version Date
December 21, 2018
Public Version Number
3
DI Record Publish Date
August 04, 2016
Package DI Number
20815149025340
Quantity per Package
2
Contains DI Package
10815149025343
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 499 |