Duns Number:079343581
Catalog Number
-
Brand Name
"maxill steri-sox Self Sealing Sterilization Pouches 12" x 17.5"
Version/Model Number
60146
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K102158,K102158
Product Code
FRG
Product Code Name
Wrap, Sterilization
Public Device Record Key
d43ebb94-6c9e-472d-96e6-dba13c5286cc
Public Version Date
November 08, 2019
Public Version Number
4
DI Record Publish Date
October 17, 2016
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 | 208 |
2 | A medical device with a moderate to high risk that requires special controls. | 61 |