Duns Number:007941230
Device Description: Sterilization Pouch -Self Seal Paper -8.75 in. x 16.5 in. -225mm x 420mm -Flat Pack -STEAM Sterilization Pouch -Self Seal Paper -8.75 in. x 16.5 in. -225mm x 420mm -Flat Pack -STEAM/EO
Catalog Number
-
Brand Name
Halyard
Version/Model Number
48542
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"
Yes
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
K153540,K153540,K153540
Product Code
FRG
Product Code Name
Wrap, sterilization
Public Device Record Key
77b66cf7-176d-4380-846a-3de56c5379bb
Public Version Date
August 20, 2020
Public Version Number
2
DI Record Publish Date
May 05, 2020
Package DI Number
30885632243992
Quantity per Package
5
Contains DI Package
10885632243998
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 | 428 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8754 |
| U | Unclassified | 1 |