Duns Number:187502109
Device Description: Multi-Specialty Cart Pull-Out Shelf with Pin Rails
Catalog Number
240-099-078
Brand Name
NA
Version/Model Number
0240099078
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
-
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
BZN
Product Code Name
CART, EMERGENCY, CARDIOPULMONARY (EXCLUDING EQUIPMENT)
Public Device Record Key
a2ea31b9-363a-4939-ac46-8b5d4576325a
Public Version Date
November 27, 2019
Public Version Number
1
DI Record Publish Date
November 19, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2188 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3183 |
| U | Unclassified | 60 |