Duns Number:103977526
Device Description: 12 Quart, 115v
Catalog Number
MT803D
Brand Name
Alloy Melter
Version/Model Number
MT803D
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 10, 2020
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
KPY
Product Code Name
Shield, protective, personnel
Public Device Record Key
be967957-5c31-4afe-bc4d-07cc91a9a23e
Public Version Date
July 10, 2020
Public Version Number
5
DI Record Publish Date
June 14, 2018
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 | 31 |
2 | A medical device with a moderate to high risk that requires special controls. | 1027 |