Duns Number:025460908
Device Description: GOWN,ISO,MICROPOROUS,LV3,WHT,REG
Catalog Number
NONLV350
Brand Name
Medline
Version/Model Number
NONLV350
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"
Yes
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FYC
Product Code Name
Gown, isolation, surgical
Public Device Record Key
ec2d9e72-b14b-4d2f-b7b9-7e33892cbe3f
Public Version Date
June 17, 2022
Public Version Number
1
DI Record Publish Date
June 09, 2022
Package DI Number
40080196765615
Quantity per Package
50
Contains DI Package
10080196765614
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 |