Duns Number:428717469
Device Description: The device is the washing (with or without ultrasounds) of surgical instruments, equipmen The device is the washing (with or without ultrasounds) of surgical instruments, equipment and objects normally used in hospital wards and medical studios.
Catalog Number
US 100 XL
Brand Name
Steelco
Version/Model Number
US 100 XL
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
FLG
Product Code Name
Cleaner, Ultrasonic, Medical Instrument
Public Device Record Key
4655c0f9-8944-4430-a979-8eb1891d32d1
Public Version Date
March 18, 2021
Public Version Number
2
DI Record Publish Date
March 01, 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 | 44 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 83 |