Duns Number:256880576
Device Description: MEDICOM PRO-TIP TURBO AIR/WATER SYRINGE
Catalog Number
1007073
Brand Name
MEDICOM PRO-TIP TURBO
Version/Model Number
1007073
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
ECB
Product Code Name
Unit, Syringe, Air And/Or Water
Public Device Record Key
dc4de926-59e3-4dba-aa3e-c6f27c2b741b
Public Version Date
March 26, 2019
Public Version Number
1
DI Record Publish Date
March 18, 2019
Package DI Number
20686864054911
Quantity per Package
6
Contains DI Package
10686864054914
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
outer case
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 84 |
2 | A medical device with a moderate to high risk that requires special controls. | 27 |
U | Unclassified | 2 |