Duns Number:001191048
Device Description: Arista AH FlexiTip Applicator
Catalog Number
AM0004
Brand Name
ARISTA™ AH FlexiTip™
Version/Model Number
AM0004
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"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LMG
Product Code Name
Agent, absorbable hemostatic, non-collagen based
Public Device Record Key
71cc45e6-0638-462b-958e-d2c44bd699ad
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 12, 2014
Package DI Number
20801741044063
Quantity per Package
5
Contains DI Package
10801741044066
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CA
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 8 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 348 |
| 3 | A medical device with high risk that requires premarket approval | 18 |