Duns Number:039576871
Device Description: ULTRA MALLEABLE SURGICAL SUCTION
Catalog Number
3101-13
Brand Name
MICROVAC®
Version/Model Number
3101-13
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"
Yes
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
JOL
Product Code Name
Catheter And Tip, Suction
Public Device Record Key
85603900-780b-4932-95e8-467e3fdf55f0
Public Version Date
August 21, 2019
Public Version Number
4
DI Record Publish Date
August 01, 2016
Package DI Number
00650551038023
Quantity per Package
12
Contains DI Package
00650551038016
Package Discontinue Date
-
Package Status
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 | 673 |
2 | A medical device with a moderate to high risk that requires special controls. | 8273 |
U | Unclassified | 1188 |