Duns Number:203383526
Device Description: with Rectal Split balloon with Introducer, 8F
Catalog Number
-
Brand Name
Cystometry Pack
Version/Model Number
9021T1021
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FEN
Product Code Name
DEVICE, CYSTOMETRIC, HYDRAULIC
Public Device Record Key
1543fd5d-22b0-4d08-8869-02a68096e450
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 21, 2016
Package DI Number
10627825007303
Quantity per Package
10
Contains DI Package
00627825007290
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. | 258 |