Duns Number:603420183
Device Description: PNEUMOSTOP® PLUS DEVICEEach sterile pouch contains one single patient use PNEUMOSTOP® PLUS PNEUMOSTOP® PLUS DEVICEEach sterile pouch contains one single patient use PNEUMOSTOP® PLUS DEVICE.
Catalog Number
110230
Brand Name
PNEUMOSTOP®
Version/Model Number
110230
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
NWW
Product Code Name
Hysteroscope accessories
Public Device Record Key
c9fc0a94-351e-4f6e-bd9d-a2749452c64a
Public Version Date
July 13, 2020
Public Version Number
1
DI Record Publish Date
July 03, 2020
Package DI Number
10850200006756
Quantity per Package
6
Contains DI Package
00850200006759
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Inner pack
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 56 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 31 |