Duns Number:092364462
Catalog Number
-
Brand Name
Medical Action / Manus
Version/Model Number
AVID268
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 01, 2019
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
FRL
Product Code Name
FIBER, MEDICAL, ABSORBENT
Public Device Record Key
1ffdc1cc-e8cb-448b-a0ed-a7a312a9877e
Public Version Date
June 07, 2019
Public Version Number
5
DI Record Publish Date
December 09, 2016
Package DI Number
30809160116368
Quantity per Package
48
Contains DI Package
20809160116361
Package Discontinue Date
February 01, 2019
Package Status
Not in Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 548 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2798 |
| U | Unclassified | 1 |