Duns Number:025460908
Device Description: DRESSING,BURN&WOUND,PLUROGEL 50G,1.75OZ
Catalog Number
PGL050
Brand Name
MEDLINE INDUSTRIES, INC.
Version/Model Number
PGL050
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
NAE
Product Code Name
Dressing, wound, hydrogel without drug and/or biologic
Public Device Record Key
393adda7-297b-47c6-8923-ba90137f683a
Public Version Date
November 19, 2020
Public Version Number
1
DI Record Publish Date
November 11, 2020
Package DI Number
20888277399362
Quantity per Package
2
Contains DI Package
10888277399365
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 |