Duns Number:690536248
Device Description: The intended use can be applied only in US.
Catalog Number
-
Brand Name
IX73 2PORT FRAME
Version/Model Number
IX73P2F
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 11, 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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
MTX
Product Code Name
Microscope And Microscope Accessories, Reproduction, Assisted
Public Device Record Key
2d92ec05-659f-4052-8156-227e527e4c09
Public Version Date
May 18, 2022
Public Version Number
2
DI Record Publish Date
September 21, 2020
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 | 31 |