Duns Number:007941230
Device Description: Sterilization Pouch -Self Seal Tyvek® -2.75 in. x 7.75 in -75mm x 200mm -Flat Pack -PLASMA
Catalog Number
-
Brand Name
Halyard
Version/Model Number
48554
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
K180139,K180139,K180139
Product Code
FRG
Product Code Name
Wrap, sterilization
Public Device Record Key
c7c3e1c3-b4b6-432d-a7a8-477ba0db493a
Public Version Date
February 05, 2021
Public Version Number
1
DI Record Publish Date
January 28, 2021
Package DI Number
30885632244111
Quantity per Package
10
Contains DI Package
20885632244114
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 |