Duns Number:557821760
Device Description: The MacoSeal SE160 is a specially designed tube sealer for dual purpose use. The device ca The MacoSeal SE160 is a specially designed tube sealer for dual purpose use. The device can work as a stand-alone tube sealer and also can be easily configured as a multi-head sealing unit. The devices can be linked in series as many number of devices as users want at spacing between 70 to 95 mm.
Catalog Number
SE160
Brand Name
MacoSeal SE160
Version/Model Number
SE160
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
9018d160-34d8-40b2-a20d-4c26a2f1a08b
Public Version Date
June 21, 2022
Public Version Number
3
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 |