Duns Number:256880576
Device Description: HEMOSTAT GAUZE 2" X 2" STERILE 4 PLY
Catalog Number
AHM0022
Brand Name
AMD-RITMED
Version/Model Number
AHM0022
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 06, 2018
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FRO
Product Code Name
Dressing, wound, drug
Public Device Record Key
2e020a59-bceb-42b8-9324-18a0d5abb9d6
Public Version Date
June 19, 2020
Public Version Number
7
DI Record Publish Date
September 15, 2016
Package DI Number
10686864919879
Quantity per Package
12
Contains DI Package
10686864909863
Package Discontinue Date
March 06, 2018
Package Status
Not in Commercial Distribution
Package Type
INNER BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 84 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 27 |
| U | Unclassified | 2 |