Duns Number:068199363
Catalog Number
-
Brand Name
CUSTOM PROCEDURE KIT
Version/Model Number
4002342
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
MNL
Product Code Name
Accessories, Cleaning Brushes, For Endoscope
Public Device Record Key
c598b1fc-842e-44a6-bf91-13366b806e19
Public Version Date
April 27, 2022
Public Version Number
3
DI Record Publish Date
August 21, 2020
Package DI Number
40677964018334
Quantity per Package
10
Contains DI Package
40677964018327
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 | 2999 |
2 | A medical device with a moderate to high risk that requires special controls. | 362 |