Duns Number:557821760
Device Description: The Rapid Seal SE540 is a space saving bench-top tube sealer with fixed sealing head and h The Rapid Seal SE540 is a space saving bench-top tube sealer with fixed sealing head and hand-held sealing unit. The device is specially designed sealers for dual purpose use. The device can be work as a stand-alone device and also the devices can be linked in series as many numbers of sealers as users want.
Catalog Number
SE540
Brand Name
Rapid Seal Tube Sealer SE540
Version/Model Number
SE540
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
51d342d7-fe4f-43b6-9cb9-bdda6a4f3651
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 |