Duns Number:025460908
Device Description: DOUBLE BASIN AND BOWL KIT
Catalog Number
NGSK3-6
Brand Name
Medline Industries, Inc.
Version/Model Number
NGSK3-6
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)
Yes
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
73b185d8-3cd4-4733-adfb-a98d2ed99f49
Public Version Date
June 17, 2022
Public Version Number
2
DI Record Publish Date
August 27, 2021
Package DI Number
40850007280053
Quantity per Package
6
Contains DI Package
10850007280052
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 38540 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 85094 |
| 3 | A medical device with high risk that requires premarket approval | 2 |
| U | Unclassified | 7 |