Duns Number:039993345
Device Description: WL07365Z, Sterilization Wrap, Performance, Green, 400 x 400 mm [] 1000 sheets/case, 2 shee WL07365Z, Sterilization Wrap, Performance, Green, 400 x 400 mm [] 1000 sheets/case, 2 sheets per application = 500 applications
Catalog Number
-
Brand Name
Sterilization Wrap, Performance, Green
Version/Model Number
WL07365400
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
FRG
Product Code Name
Wrap, Sterilization
Public Device Record Key
3e505e42-87e6-4c69-bd4b-b45d9cba6674
Public Version Date
November 08, 2019
Public Version Number
3
DI Record Publish Date
August 23, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 13 |