Duns Number:184763290
Catalog Number
TC80
Brand Name
TRAP CAPtain™
Version/Model Number
00884450278734
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)
-
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
82cbfc08-5ec6-4664-8ab3-a9e93ef60e50
Public Version Date
October 29, 2021
Public Version Number
2
DI Record Publish Date
March 12, 2019
Package DI Number
10884450278731
Quantity per Package
10
Contains DI Package
00884450278734
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 573 |
2 | A medical device with a moderate to high risk that requires special controls. | 8779 |