Duns Number:600030209
Device Description: Sterilizer,steam
Catalog Number
6690LM-1V-USA
Brand Name
Model 6690-1V
Version/Model Number
Model 6690-1V
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
K181456
Product Code
FLE
Product Code Name
Sterilizer, Steam
Public Device Record Key
90b35b2f-0d34-4243-89c9-f9d94b11e8ae
Public Version Date
January 13, 2020
Public Version Number
1
DI Record Publish Date
January 05, 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 |