Duns Number:152793493
Device Description: Non-Stick Pads, all one size, 3 IN x 4 IN (76 mm x 101 mm)
Catalog Number
-
Brand Name
ALL-HEALTH Wound Care Products
Version/Model Number
017276234442
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
NAC
Product Code Name
Dressing, Wound, Hydrophilic
Public Device Record Key
47b922ec-8c53-4d5c-86c1-3384c7f7bca7
Public Version Date
August 24, 2021
Public Version Number
2
DI Record Publish Date
February 28, 2020
Package DI Number
20017276234446
Quantity per Package
12
Contains DI Package
00017276234442
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 | 48 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4 |
| U | Unclassified | 1 |