Duns Number:042763706
Device Description: ACE EXTENSION TUBE 20" STER 3CC VOLUME L/F 100/CA
Catalog Number
0030020
Brand Name
ACE
Version/Model Number
0030020
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
FPX
Product Code Name
Strip, adhesive, closure, skin
Public Device Record Key
c2117d73-9d00-4d4e-a451-51b9aa51d5fb
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
February 24, 2017
Package DI Number
10614950008800
Quantity per Package
100
Contains DI Package
00614950008803
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1288 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 943 |
| U | Unclassified | 6 |