Duns Number:078375583
Device Description: Five level processing rack, with 4 rotating arms, holds 10 trays up to 19" x 10" x 2"
Catalog Number
I5-5LR
Brand Name
I-Series Washers
Version/Model Number
I5-5LR
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)
Yes
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
53ac9c8c-f25c-45f8-8799-6c6fbb8c3972
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 19, 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 | 747 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 265 |