Duns Number:806136177
Device Description: SI BRITE TIP 10F 11CM
Catalog Number
401011M
Brand Name
BRITE TIP
Version/Model Number
401011M
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
DYB
Product Code Name
INTRODUCER, CATHETER
Public Device Record Key
7e9f86b8-c9db-4902-aa95-fd88a770cf33
Public Version Date
September 14, 2022
Public Version Number
9
DI Record Publish Date
August 01, 2016
Package DI Number
20705032000113
Quantity per Package
5
Contains DI Package
10705032000116
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 2567 |
3 | A medical device with high risk that requires premarket approval | 204 |