Duns Number:081057389
Device Description: HALYARD* STERILE WRAP AND CONTAINER FILTERS -Round 7.5 in.
Catalog Number
68507
Brand Name
Halyard
Version/Model Number
68507
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
92cae04d-a57f-4fce-b361-2f35dcd3ac4e
Public Version Date
November 08, 2019
Public Version Number
5
DI Record Publish Date
September 30, 2016
Package DI Number
30680651685071
Quantity per Package
4
Contains DI Package
10680651685077
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CS
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 24 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1044 |