Duns Number:005875146
Device Description: Intussusception Air Reduction kit, no tip
Catalog Number
IARK-1
Brand Name
Intussusception Air Reduction kit, no tip
Version/Model Number
IARK-1
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KQT
Product Code Name
Evacuator, Gastro-Urology
Public Device Record Key
398457b4-88d8-440d-ba9d-6b030e524b34
Public Version Date
December 26, 2019
Public Version Number
1
DI Record Publish Date
December 18, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 7 |