Duns Number:025460908
Device Description: DRESSING,ADHESIVE,SURGICAL,4X6,(4X3 PAD)
Catalog Number
NON4311
Brand Name
MEDLINE INDUSTRIES, INC.
Version/Model Number
NON4311
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
KGX
Product Code Name
Tape and bandage, adhesive
Public Device Record Key
6c37dd25-631f-4339-b28e-f402f7e0c060
Public Version Date
March 02, 2021
Public Version Number
1
DI Record Publish Date
February 22, 2021
Package DI Number
40080196757030
Quantity per Package
200
Contains DI Package
10080196757039
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 |