Duns Number:042075700
Device Description: The ExpressAR Belt Kit provides a non-sterile Belt and a sterile Jumbo SuperComfort Disc ( The ExpressAR Belt Kit provides a non-sterile Belt and a sterile Jumbo SuperComfort Disc (2.625” dia.) for use with the ExpressAR device.
Catalog Number
160-2027-00
Brand Name
ExpressAR Belt Kit
Version/Model Number
160-2027-00
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
K970027,K970027
Product Code
DXC
Product Code Name
Clamp, Vascular
Public Device Record Key
9ba65b96-3906-4f7a-acb3-1b8dfe3c9437
Public Version Date
November 22, 2018
Public Version Number
6
DI Record Publish Date
September 24, 2016
Package DI Number
20815614020665
Quantity per Package
15
Contains DI Package
10815614020668
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 27 |
| U | Unclassified | 1 |