Duns Number:069936106
Device Description: 5 STD DECON GWN, LG N/S
Catalog Number
8508
Brand Name
NOVO Health Services, LLC
Version/Model Number
8508
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
-
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
K920404
Product Code
FYC
Product Code Name
Gown, Isolation, Surgical
Public Device Record Key
af80db3b-607c-49ff-9ad9-c1387561d96e
Public Version Date
November 01, 2018
Public Version Number
1
DI Record Publish Date
October 01, 2018
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 | 226 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 859 |