Duns Number:006261481
Device Description: CATHETER 990063-020 ACHIEVE 20M US
Catalog Number
-
Brand Name
ACHIEVE™
Version/Model Number
990063-020
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 21, 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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K102588
Product Code
DRF
Product Code Name
CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
Public Device Record Key
ae0f5c92-7adb-4fab-8a4d-f9b688713edb
Public Version Date
July 06, 2018
Public Version Number
4
DI Record Publish Date
April 08, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 102 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 20495 |
| 3 | A medical device with high risk that requires premarket approval | 3601 |