Duns Number:027532357
Catalog Number
-
Brand Name
Burkhart Select Multivariable Sterilezation Pouch 3 1/2 x 5 1/4 (200)
Version/Model Number
72720663
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
Yes
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
KCT
Product Code Name
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Public Device Record Key
e34da53b-7746-4539-bfea-15f1f371205a
Public Version Date
November 08, 2019
Public Version Number
3
DI Record Publish Date
September 16, 2016
Package DI Number
10815878020121
Quantity per Package
10
Contains DI Package
00815878020124
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 214 |
2 | A medical device with a moderate to high risk that requires special controls. | 43 |