Duns Number:428717469
Device Description: The device is the washing (with or without ultrasounds) of surgical instruments, equipment 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 1000
Brand Name
Steelco
Version/Model Number
US 1000
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
a41716f6-eff7-42cf-969c-aafaf8b75726
Public Version Date
March 18, 2021
Public Version Number
3
DI Record Publish Date
November 12, 2019
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 |