Duns Number:600030209
Device Description: Sterilizer,steam
Catalog Number
4472-2V
Brand Name
Model 4472
Version/Model Number
4472-2V
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
K032192
Product Code
PDG
Product Code Name
Electrosurgical Vessel And/Or Tissue Sealer. With Built-In Generator.
Public Device Record Key
e225b33b-40c5-47c4-b60b-a6576689d01c
Public Version Date
December 16, 2020
Public Version Number
1
DI Record Publish Date
December 08, 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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 70 |