Duns Number:086911794
Device Description: A non-medicated sterile device in the form of a patch, with clips, made from non-woven mat A non-medicated sterile device in the form of a patch, with clips, made from non-woven material (e.g., rayon/polyester) and primarily designed to absorb fluids for medical purposes.
Catalog Number
6381B
Brand Name
Medi-First 3" Compress Bandage with Clips
Version/Model Number
6381B
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"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
NAC
Product Code Name
Dressing, Wound, Hydrophilic
Public Device Record Key
67295076-e5f3-4d1b-97ca-ca5e09057c38
Public Version Date
February 21, 2022
Public Version Number
3
DI Record Publish Date
July 19, 2019
Package DI Number
50347682638103
Quantity per Package
30
Contains DI Package
00347682638108
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
master case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 110 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |
| U | Unclassified | 1 |