Duns Number:039993345
Device Description: WL11395D, Sterilization Wrap, Economy, Blue, 12 x 12 inches [] 1000 sheets/case, 2 sheets WL11395D, Sterilization Wrap, Economy, Blue, 12 x 12 inches [] 1000 sheets/case, 2 sheets per application = 500 applications
Catalog Number
-
Brand Name
Sterilization Wrap, Economy, Blue
Version/Model Number
WL1139512
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
0b683a9f-bb1b-4e7e-91ce-0a86e7730a4e
Public Version Date
November 08, 2019
Public Version Number
2
DI Record Publish Date
June 07, 2019
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 |