Duns Number:332599307
Device Description: MLIC "Zebra" kpl.
Catalog Number
-
Brand Name
MLIC "Zebra" kpl.
Version/Model Number
E6000000
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
K092018,K092018
Product Code
IYE
Product Code Name
Accelerator, Linear, Medical
Public Device Record Key
ae2199e8-d1a7-4244-89bb-2b21c2ff731f
Public Version Date
December 27, 2021
Public Version Number
3
DI Record Publish Date
September 09, 2016
Package DI Number
EIBAE60000001
Quantity per Package
1
Contains DI Package
EIBAE60000000
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Transport case
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 89 |
2 | A medical device with a moderate to high risk that requires special controls. | 177 |