Duns Number:256880576
Device Description: HEMOSTAT GAUZE 4" X 4" STERILE
Catalog Number
AHM0044
Brand Name
AMD-RITMED
Version/Model Number
AHM0044
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
06c25d45-129a-46d4-880b-4cf2987dd2a4
Public Version Date
June 19, 2020
Public Version Number
7
DI Record Publish Date
September 15, 2016
Package DI Number
20686864969925
Quantity per Package
80
Contains DI Package
10686864979934
Package Discontinue Date
March 06, 2018
Package Status
Not in Commercial Distribution
Package Type
OUTER CASE
| 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 |