Duns Number:079116867
Device Description: EM XM Cleaning and Sterilization Basket - Insert
Catalog Number
EX-BSKT-INS
Brand Name
NA
Version/Model Number
EX-BSKT-INS
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 18, 2022
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
LRP
Product Code Name
TRAY, SURGICAL
Public Device Record Key
bc2aa64b-31a7-4064-8729-cce43a7d8c08
Public Version Date
March 18, 2022
Public Version Number
4
DI Record Publish Date
February 05, 2018
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 | 294 |
2 | A medical device with a moderate to high risk that requires special controls. | 910 |