Duns Number:961027315
Device Description: Tomac Lukens Tube 8CC, 3 1/4"
Catalog Number
19510-035
Brand Name
ALLEGIANCE
Version/Model Number
19510-035
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)
Yes
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
BYZ
Product Code Name
TRAP, STERILE SPECIMEN
Public Device Record Key
3eb6c1e7-2708-472a-9d13-385e0a4a2749
Public Version Date
July 19, 2018
Public Version Number
3
DI Record Publish Date
September 19, 2017
Package DI Number
20885380114479
Quantity per Package
12
Contains DI Package
10885380114472
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 | 101686 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 139430 |
| 3 | A medical device with high risk that requires premarket approval | 8 |
| U | Unclassified | 40 |