Duns Number:042763706
Device Description: SUCTION CONN TUBE 1' STERILE FOR AUTOGRAFTER L/F
Catalog Number
0030276
Brand Name
ACE
Version/Model Number
0030276
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
EBR
Product Code Name
UNIT, SUCTION OPERATORY
Public Device Record Key
65858e79-516d-4afb-90b2-b287c70add6f
Public Version Date
June 08, 2021
Public Version Number
2
DI Record Publish Date
October 13, 2019
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 | 1288 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 943 |
| U | Unclassified | 6 |