Duns Number:025460908
Device Description: GOWN,NON-REINFORCED,XXL,PINK
Catalog Number
PINK2003S
Brand Name
Medline
Version/Model Number
PINK2003S
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
FME
Product Code Name
GOWN, EXAMINATION
Public Device Record Key
43629f1c-0294-4969-84db-3769ae6d766a
Public Version Date
April 07, 2021
Public Version Number
4
DI Record Publish Date
October 14, 2016
Package DI Number
40888277197832
Quantity per Package
18
Contains DI Package
10888277197831
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| 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 |