Duns Number:343189676
Device Description: Peritoneal Catheter with integr. Barium strip (900 mm), inner diam. 1,20 mm, outer diam. 2 Peritoneal Catheter with integr. Barium strip (900 mm), inner diam. 1,20 mm, outer diam. 2,50 mm, silicone, sterile, disposable
Catalog Number
FV091P
Brand Name
AESCULAP
Version/Model Number
FV091P
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 25, 2021
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
JXG
Product Code Name
Shunt, central nervous system and components
Public Device Record Key
534e3075-c3bd-4d8c-8a67-7ba2244ea019
Public Version Date
March 26, 2021
Public Version Number
6
DI Record Publish Date
September 24, 2015
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. | 630 |