Duns Number:007941230
Device Description: Trap Specimen Mucous Vacuum Breaker With 10 French Catheter 20 Cubic Centimeter Polyuretha Trap Specimen Mucous Vacuum Breaker With 10 French Catheter 20 Cubic Centimeter Polyurethane Sterile Not Made With Natural Rubber Latex MediChoice
Catalog Number
-
Brand Name
Medichoice
Version/Model Number
MST2010
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"
Yes
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
f9159a16-d99e-410e-8aae-55075d7cbae3
Public Version Date
June 18, 2021
Public Version Number
1
DI Record Publish Date
June 10, 2021
Package DI Number
50885632120341
Quantity per Package
50
Contains DI Package
10885632120343
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 | 428 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8754 |
| U | Unclassified | 1 |