Duns Number:556196210
Device Description: INSTALLATION - ISOLET PLATES * SET OF TWO ATTACHMENT PLATES
Catalog Number
-
Brand Name
Incubator Attachment Plates
Version/Model Number
AS1-014-01
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
FOX
Product Code Name
Stand, Infusion
Public Device Record Key
72de5c1d-0c47-43d5-abc0-a628cf2318a5
Public Version Date
July 29, 2021
Public Version Number
1
DI Record Publish Date
July 21, 2021
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 | 213 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6 |