Duns Number:086911794
Device Description: A sterile hydrophilic wound dressing non-adherent pad intended to cover a wound and to abs A sterile hydrophilic wound dressing non-adherent pad intended to cover a wound and to absorb exudate.
Catalog Number
89801
Brand Name
Medi-First Combine ABD Pad
Version/Model Number
89801
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)
-
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
3e65734d-222b-475e-bcd7-05940348a4c7
Public Version Date
August 24, 2021
Public Version Number
2
DI Record Publish Date
July 12, 2019
Package DI Number
50347682898019
Quantity per Package
400
Contains DI Package
00347682898014
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 |