Duns Number:557821760
Device Description: The Rapid Seal SE530 is a space saving bench-top tube sealer with fixed sealing head makes The Rapid Seal SE530 is a space saving bench-top tube sealer with fixed sealing head makes it for use in a limited space. The unit can work as a stand-alone device and also can be easily linked as a multi-head sealing unit as user want.
Catalog Number
SE530
Brand Name
Rapid Seal Tube Sealer SE530
Version/Model Number
SE530
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
KSD
Product Code Name
Device, Heat-Sealing
Public Device Record Key
585c46a2-b8f1-4a3d-8995-0bbbdd35bb82
Public Version Date
July 07, 2020
Public Version Number
2
DI Record Publish Date
April 03, 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 | 10 |