Duns Number:825673239
Device Description: RECEPTAL™ TANDEM FLOOR STAND, STAINLESS STEEL WITH ROLLERS, CONDUCTIVE CASTERS
Catalog Number
434329211
Brand Name
RECEPTAL™ TANDEM FLOOR STAND, STAINLESS STEEL WITH ROLLERS, CONDUCTIVE CASTERS
Version/Model Number
1
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GCX
Product Code Name
Apparatus, Suction, Operating-Room, Wall Vacuum Powered
Public Device Record Key
b3ec814f-8562-47a3-8bb9-26b8845acd39
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
January 05, 2017
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 | 89 |
2 | A medical device with a moderate to high risk that requires special controls. | 411 |
U | Unclassified | 1 |