Duns Number:006261481
Device Description: FILTER 7260 MEDTRONIC O2 STERILE 25PK
Catalog Number
-
Brand Name
Intersept®
Version/Model Number
7260
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
K882136,K882136
Product Code
KRD
Product Code Name
Device, Vascular, for Promoting Embolization
Public Device Record Key
4b0eafe4-36fb-4c98-a370-ff9ca2c812ab
Public Version Date
July 12, 2019
Public Version Number
4
DI Record Publish Date
June 09, 2015
Package DI Number
20673978555564
Quantity per Package
25
Contains DI Package
00673978555560
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
PK
| 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 |