Duns Number:006261481
Device Description: TORQUE HANDLE AC4006 TJM 5PK
Catalog Number
-
Brand Name
NA
Version/Model Number
AC4006
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
K945461,K945461
Product Code
DTL
Product Code Name
Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass
Public Device Record Key
5d089b29-6c22-4ca2-a2ef-a9b4cd8342c3
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
October 02, 2016
Package DI Number
20643169002962
Quantity per Package
5
Contains DI Package
00643169002968
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 |