Duns Number:688385418
Device Description: Bed Rail Clamp
Catalog Number
GS138-7101
Brand Name
AnyPlus®
Version/Model Number
GS138-7101
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
HXD
Product Code Name
Clamp
Public Device Record Key
5a3540fd-c819-43f5-b848-4bf681096918
Public Version Date
April 21, 2021
Public Version Number
2
DI Record Publish Date
September 22, 2020
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 | 280 |
2 | A medical device with a moderate to high risk that requires special controls. | 7396 |