Duns Number:965484699
Catalog Number
BL-2024
Brand Name
N/A
Version/Model Number
BL-2024
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 18, 2021
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
-
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
KDC
Product Code Name
Instrument, Surgical, Disposable
Public Device Record Key
75f3adc5-5c73-4887-859f-80ef243535d9
Public Version Date
August 23, 2021
Public Version Number
6
DI Record Publish Date
August 15, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 1100 |
2 | A medical device with a moderate to high risk that requires special controls. | 4771 |
U | Unclassified | 10 |