Duns Number:039993345
Device Description: WLJ5Z1120B, Sterilization Wrap, Reliance Solo 400, 36 x 36 inches [] 144 sheets/case, 2 bo WLJ5Z1120B, Sterilization Wrap, Reliance Solo 400, 36 x 36 inches [] 144 sheets/case, 2 bonded sheets per application = 72 applications/case. Wrap with Green layer on outside. Review IFU.
Catalog Number
-
Brand Name
Sterilization Wrap, Reliance Solo S400
Version/Model Number
WLJ5Z1120B36
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
3bd5866c-b45e-4c50-9b4c-f2e114a3744c
Public Version Date
April 19, 2021
Public Version Number
1
DI Record Publish Date
April 09, 2021
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 |