Duns Number:058614483
Device Description: MSS-4581-3D MANOSHIELD 3DAR - BOX 10
Catalog Number
MSS-4581-3D
Brand Name
ManoScan
Version/Model Number
MSS-4581-3D
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
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K151086,K151086
Product Code
NEZ
Product Code Name
SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE
Public Device Record Key
0e04eb60-0904-4c9d-abcf-bc2fbe8f55bd
Public Version Date
November 08, 2019
Public Version Number
4
DI Record Publish Date
May 24, 2018
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 132 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8540 |
| 3 | A medical device with high risk that requires premarket approval | 202 |
| U | Unclassified | 40 |