Duns Number:102354446
Device Description: Midway Everyday Autoclave Pouches 5 1/4 x 10
Catalog Number
-
Brand Name
Midway Everyday
Version/Model Number
002-0362
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
K162258,K162258
Product Code
FRG
Product Code Name
Wrap, Sterilization
Public Device Record Key
97bb8d86-5209-4834-809e-c632df864640
Public Version Date
November 25, 2019
Public Version Number
1
DI Record Publish Date
November 15, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 183 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 43 |