Duns Number:007941230
Device Description: Sterilization Pouch - Heat Seal Paper - 15.5 in. x 656' - 400mm x 200m - Flat Reel - STEAM Sterilization Pouch - Heat Seal Paper - 15.5 in. x 656' - 400mm x 200m - Flat Reel - STEAM/EO
Catalog Number
-
Brand Name
Halyard
Version/Model Number
48556
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
Product Code
FRG
Product Code Name
Wrap, sterilization
Public Device Record Key
044a4bac-8d72-44fe-bd14-439a412f8e23
Public Version Date
May 13, 2020
Public Version Number
1
DI Record Publish Date
May 05, 2020
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 | 428 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8754 |
| U | Unclassified | 1 |