Duns Number:354023236
Device Description: WASHER DISINFECTORCatalog number was S-86681001.Catalog number updated to S-86682001 in No WASHER DISINFECTORCatalog number was S-86681001.Catalog number updated to S-86682001 in November 2018.
Catalog Number
S-86682001
Brand Name
GETINGE 86-SERIES
Version/Model Number
S-8668
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
MEC
Product Code Name
Disinfector, Medical Devices
Public Device Record Key
fb76bdd5-2d40-4224-9c02-4c00bbe4aa45
Public Version Date
November 29, 2018
Public Version Number
3
DI Record Publish Date
September 22, 2016
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 | 9 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 40 |