Duns Number:025460908
Device Description: DRESSING,PLUROGEL, 20G, TUBE
Catalog Number
PGL020
Brand Name
MEDLINE INDUSTRIES
Version/Model Number
PGL020
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
-
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
dd90b574-f366-4eff-86c1-74fe2ee96c00
Public Version Date
October 25, 2021
Public Version Number
1
DI Record Publish Date
October 16, 2021
Package DI Number
20888277698618
Quantity per Package
35
Contains DI Package
10888277698611
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 |